Overview Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. As our Senior CDISC Consultant, you will be responsible for: Educating and consulting internal and external Pinnacle 21 customers, including but not limited to: Product Leaders, Customer Success, Sales Enablement and Operations. Leading multi-disciplinary functions within the Standards Consulting team by establishing and executing the strategic vision of Certara's data science software solutions. Guiding Product teams and influencing prioritization of solution development based on user stories and your significant industry experience. Continuously contributing to the industry as a thought leader, including presenting at events, developing educational materials, and providing guidance to industry leaders. Responsibilities Advocate and Communicator Explains the product in detail proactively to internal (e.g., sales) audiences and clients via well-produced help articles/videos and other media; attends tradeshows to drive adoption and produces multiple publications or presentations per year (company webinars, industry journals, 3rd party conferences, etc.)-with external industry recognition as an expert in the field. Collaborate with Customer Success team to ensure customers are aware and educated on the company's latest solutions and features. Contribute to release prioritization based on deep domain knowledge. Escalate issues to Support, Customer Success and/or Sales. Strategy and Planning Guide continued development of Metadata Management software solutions. Help define and execute strategy of Standards Consulting team, including process, organizational capacities, resource management, and technology enablement. Operational Management Identify a process that provides advanced support for internal and external customers. Develop and train SOPs related to Standards Management. Develop and maintain a central repository of domain-specific knowledge for internal knowledge sharing, which enables external communication and education. Qualifications • Minimum 10 years' experience with clinical trial data regulatory submission requirements • Education/experience relating to clinical trials data standards, including expert-level CDISC domain knowledge. • Thought-leadership experience including developing and presenting novel content and participation in industry groups. • Willing and able to travel approximately 10% of the time. Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Jul 06, 2025
Full time
Overview Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. As our Senior CDISC Consultant, you will be responsible for: Educating and consulting internal and external Pinnacle 21 customers, including but not limited to: Product Leaders, Customer Success, Sales Enablement and Operations. Leading multi-disciplinary functions within the Standards Consulting team by establishing and executing the strategic vision of Certara's data science software solutions. Guiding Product teams and influencing prioritization of solution development based on user stories and your significant industry experience. Continuously contributing to the industry as a thought leader, including presenting at events, developing educational materials, and providing guidance to industry leaders. Responsibilities Advocate and Communicator Explains the product in detail proactively to internal (e.g., sales) audiences and clients via well-produced help articles/videos and other media; attends tradeshows to drive adoption and produces multiple publications or presentations per year (company webinars, industry journals, 3rd party conferences, etc.)-with external industry recognition as an expert in the field. Collaborate with Customer Success team to ensure customers are aware and educated on the company's latest solutions and features. Contribute to release prioritization based on deep domain knowledge. Escalate issues to Support, Customer Success and/or Sales. Strategy and Planning Guide continued development of Metadata Management software solutions. Help define and execute strategy of Standards Consulting team, including process, organizational capacities, resource management, and technology enablement. Operational Management Identify a process that provides advanced support for internal and external customers. Develop and train SOPs related to Standards Management. Develop and maintain a central repository of domain-specific knowledge for internal knowledge sharing, which enables external communication and education. Qualifications • Minimum 10 years' experience with clinical trial data regulatory submission requirements • Education/experience relating to clinical trials data standards, including expert-level CDISC domain knowledge. • Thought-leadership experience including developing and presenting novel content and participation in industry groups. • Willing and able to travel approximately 10% of the time. Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Overview Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries. The Associate Director will be responsible for dDesigning, developing, and maintaining R-based tools and workflows for drug discovery, data analysis, and computational simulations. Should be able to adapt existing R scripts and update them to meet new requirements. Ensure code is clean, efficient, and well-documented. Will work closely with cross-functional teams, including the model-based meta-analysis team, data scientists, and software engineers, to support project goals and deliver technical solutions. Will provide analysis of large datasets related to drug efficacy, pharmacokinetics, and other biological data. Develop statistical models, predictive analytics, and visualizations to inform decision-making in drug development. Responsibilities Validate other team members' work via independent programming in R Implement and optimize algorithms for processing and analyzing data, with a focus on optimizing the CODEX database. Develop custom R packages and integrate existing tools with external systems, databases, and platforms (e.g., cloud infrastructure, computational frameworks). Ensure high code quality and reproducibility of analyses. Perform unit testing, debugging, and troubleshooting issues related to the codebase. Document methodologies, workflows, and results to facilitate knowledge sharing within the team and organization. Prepare reports and presentations as needed for internal and external stakeholders. Participate in the development of standards and create efficient processes. Collaborate with the project team to ensure timely delivery and quality of all programming-related deliverables Mentor junior programmers. May also be responsible for managing other programmers if needed. May provide operational support, including the ongoing development and improvement of business practices and processes. Support the project team in all aspects of programming activities. Qualifications Bachelor's or Master's degree in Computer Science, Bioinformatics, Statistics, Mathematics, Pharmaceutical Sciences, or a related field Proven experience programming in R, including data manipulation, statistical modeling, and visualization (experience with packages such as ggplot2, dplyr, shiny, tidyr, etc.). Experience working in bioinformatics, pharmacometrics, or computational biology is a plus. Experience with relational databases (e.g., SQL) and knowledge of data integration practices. Ability to prioritize and manage multiple projects in a fast-paced, deadline-driven environment while delivering high-quality results. A quick learner able to rapidly grasp and master new/changing business needs. Excellent communication skills in English, and ability to adapt communication styles to varied internal and external partners. Strong problem-solving skills and attention to detail. Ability to work independently within a team environment. Ability to collaborate with other team members and across business units. Strong problem-solving skills and the ability to apply computational methods to complex biological and pharmaceutical problems. Understanding of statistical analysis and predictive modeling techniques. Familiarity with Git for version control and collaborative coding. Familiarity with machine learning approaches and data mining is an advantage. R programming, RStudio, Shiny, and related R libraries for analysis and visualization. Basic knowledge of Python and/or other programming languages (e.g., C++, Java) is a plus. Familiarity with cloud platforms, data storage, and high-performance computing environments is a plus. Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Jun 28, 2025
Full time
Overview Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries. The Associate Director will be responsible for dDesigning, developing, and maintaining R-based tools and workflows for drug discovery, data analysis, and computational simulations. Should be able to adapt existing R scripts and update them to meet new requirements. Ensure code is clean, efficient, and well-documented. Will work closely with cross-functional teams, including the model-based meta-analysis team, data scientists, and software engineers, to support project goals and deliver technical solutions. Will provide analysis of large datasets related to drug efficacy, pharmacokinetics, and other biological data. Develop statistical models, predictive analytics, and visualizations to inform decision-making in drug development. Responsibilities Validate other team members' work via independent programming in R Implement and optimize algorithms for processing and analyzing data, with a focus on optimizing the CODEX database. Develop custom R packages and integrate existing tools with external systems, databases, and platforms (e.g., cloud infrastructure, computational frameworks). Ensure high code quality and reproducibility of analyses. Perform unit testing, debugging, and troubleshooting issues related to the codebase. Document methodologies, workflows, and results to facilitate knowledge sharing within the team and organization. Prepare reports and presentations as needed for internal and external stakeholders. Participate in the development of standards and create efficient processes. Collaborate with the project team to ensure timely delivery and quality of all programming-related deliverables Mentor junior programmers. May also be responsible for managing other programmers if needed. May provide operational support, including the ongoing development and improvement of business practices and processes. Support the project team in all aspects of programming activities. Qualifications Bachelor's or Master's degree in Computer Science, Bioinformatics, Statistics, Mathematics, Pharmaceutical Sciences, or a related field Proven experience programming in R, including data manipulation, statistical modeling, and visualization (experience with packages such as ggplot2, dplyr, shiny, tidyr, etc.). Experience working in bioinformatics, pharmacometrics, or computational biology is a plus. Experience with relational databases (e.g., SQL) and knowledge of data integration practices. Ability to prioritize and manage multiple projects in a fast-paced, deadline-driven environment while delivering high-quality results. A quick learner able to rapidly grasp and master new/changing business needs. Excellent communication skills in English, and ability to adapt communication styles to varied internal and external partners. Strong problem-solving skills and attention to detail. Ability to work independently within a team environment. Ability to collaborate with other team members and across business units. Strong problem-solving skills and the ability to apply computational methods to complex biological and pharmaceutical problems. Understanding of statistical analysis and predictive modeling techniques. Familiarity with Git for version control and collaborative coding. Familiarity with machine learning approaches and data mining is an advantage. R programming, RStudio, Shiny, and related R libraries for analysis and visualization. Basic knowledge of Python and/or other programming languages (e.g., C++, Java) is a plus. Familiarity with cloud platforms, data storage, and high-performance computing environments is a plus. Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Overview About Certara Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. Responsibilities Oversee accounting operations and ensure duties are fulfilled and appropriately segregated. Conduct comprehensive reviews of financial statements to ensure accuracy, completeness, and adherence to regulatory standards. Supervise and mentor the accounting team responsible for accounting, payroll, VAT, HRMC processes, fostering a culture of continuous improvement and professional development. Lead the end-to-end audit process of current systems, while acting as a point of contact for auditors. Develop and implement internal controls in collaboration with Corporate to ensure the accuracy and security of financial data. Maintain thorough documentation to support audits and ensure smooth processes. Ensure adherence to accounting standards (GAAP), tax regulations, and internal controls, supporting audit standards. Review the financial reports and seek ways to reduce company costs. Propose solutions to identified risks, and effectively manage stakeholder expectations. Control the preparation and interpretation of statutory accounts and present findings. Drive the continuous improvement of end-to-end accounting practices. Support in the development and management of annual budgets, forecast future financial performance, and monitor variances against budget. Oversee revenue recognition, monthly reporting and forecasting of the CPT Business units located in the US. Develop KPI dashboard reporting for CPT Business. Create monthly and annual reports to identify results, trends, and financial forecasts. Conduct detailed reviews of balance sheet reconciliations. Review and approve general journal entries posted by accounting staff. Manage the month-end and year-end close process and prepare financial reporting packages for all CPT entities. Oversee the management of accounts receivable and accounts payable ledgers. Manage cash flow by tracking transactions and regularly reviewing internal reports. Collaborate with cross-functional teams to gather financial data and provide insights for strategic decision-making. Qualifications Qualified ACCA/CIMA/ACA with a minimum of two years' post-qualification experience. Significant experience in the use of Microsoft Office suite of applications including Excel, PowerPoint, Power BI, and Outlook. Demonstrates leadership capability and the ability to influence others. Excellent presentation and communication skills. Effective communication skills, with the ability to articulate complex financial concepts to stakeholders at all levels. Adaptable to change and possess a willingness to embrace innovative ideas and new processes. Strong knowledge of GAAP and financial reporting standards. Demonstrate positivity, approachability and have an investigative nature. Ability to analyze, understand and manipulate data in order to present clear and concise financial messages for review. Exceptional technical accounting knowledge. Previous experience in a Financial Controlling role of a similar sized/complexity business. Experience in Corporate tax and Internal Controls. Experience in Netsuite accounting software and Salesforce. US GAAP Experience. Extensive working knowledge of financial regulations and legislation including revenue recognition standards. Certara bases all employment-related decisions on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Feb 20, 2025
Full time
Overview About Certara Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. Responsibilities Oversee accounting operations and ensure duties are fulfilled and appropriately segregated. Conduct comprehensive reviews of financial statements to ensure accuracy, completeness, and adherence to regulatory standards. Supervise and mentor the accounting team responsible for accounting, payroll, VAT, HRMC processes, fostering a culture of continuous improvement and professional development. Lead the end-to-end audit process of current systems, while acting as a point of contact for auditors. Develop and implement internal controls in collaboration with Corporate to ensure the accuracy and security of financial data. Maintain thorough documentation to support audits and ensure smooth processes. Ensure adherence to accounting standards (GAAP), tax regulations, and internal controls, supporting audit standards. Review the financial reports and seek ways to reduce company costs. Propose solutions to identified risks, and effectively manage stakeholder expectations. Control the preparation and interpretation of statutory accounts and present findings. Drive the continuous improvement of end-to-end accounting practices. Support in the development and management of annual budgets, forecast future financial performance, and monitor variances against budget. Oversee revenue recognition, monthly reporting and forecasting of the CPT Business units located in the US. Develop KPI dashboard reporting for CPT Business. Create monthly and annual reports to identify results, trends, and financial forecasts. Conduct detailed reviews of balance sheet reconciliations. Review and approve general journal entries posted by accounting staff. Manage the month-end and year-end close process and prepare financial reporting packages for all CPT entities. Oversee the management of accounts receivable and accounts payable ledgers. Manage cash flow by tracking transactions and regularly reviewing internal reports. Collaborate with cross-functional teams to gather financial data and provide insights for strategic decision-making. Qualifications Qualified ACCA/CIMA/ACA with a minimum of two years' post-qualification experience. Significant experience in the use of Microsoft Office suite of applications including Excel, PowerPoint, Power BI, and Outlook. Demonstrates leadership capability and the ability to influence others. Excellent presentation and communication skills. Effective communication skills, with the ability to articulate complex financial concepts to stakeholders at all levels. Adaptable to change and possess a willingness to embrace innovative ideas and new processes. Strong knowledge of GAAP and financial reporting standards. Demonstrate positivity, approachability and have an investigative nature. Ability to analyze, understand and manipulate data in order to present clear and concise financial messages for review. Exceptional technical accounting knowledge. Previous experience in a Financial Controlling role of a similar sized/complexity business. Experience in Corporate tax and Internal Controls. Experience in Netsuite accounting software and Salesforce. US GAAP Experience. Extensive working knowledge of financial regulations and legislation including revenue recognition standards. Certara bases all employment-related decisions on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Overview About Certara Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. The Certara Quantitative Systems Pharmacology (QSP) group is a global organization focused on the impactful application of QSP and mechanistic PKPD modeling and simulation in drug discovery and development. We are leading several first-of-its-kind QSP Consortia with more than 10 global pharmaceutical companies and have a rapidly expanding consultancy portfolio. Our QSP scientists work in close collaboration with other Certara staff and clients to generate and use state-of-the-art mechanistic models for decision making in pharmaceutical R&D. The models are designed in close dialogue with clients and developed with a view to creating user-friendly tools that will inform drug development programs from discovery to regulatory filing. We have unique capability to seamlessly integrate bespoke QSP models into the Simcyp physiologically based pharmacokinetic (PBPK) platform. Besides our well-established leadership in applied QSP approaches in Immunology and Immuno-Oncology, we are now also the leading provider of QSP approaches in neuro-degenerative diseases through Certara's recent acquisition of the In Silico Biosciences modelling platform. We are seeking highly motivated and talented QSP modelling experts at all levels, who share our passion for using quantitative approaches to understand and impact complex drug discovery and development questions. Positions are available at various levels of experience across our global locations and for flexible, home-based roles. Responsibilities Technical Postdoctoral experience in systems modelling for drug discovery/ development teams. PhD (or equivalent) in life sciences, engineering, computer sciences, mathematics physics or equivalent. Good understanding of PKPD, pharmacology and biology and its application in drug discovery and development. Very familiar and outstanding hands-on expertise with Matlab, Neuron or other similar modelling software. Strong publication record (commensurate with level of experience). Team working Excellent interpersonal skills. Skilled and experienced at facilitating a multi-disciplinary team to work together on a complex project. Ability to communicate with all stakeholders clearly and efficiently. Organised and with track record of delivering quality results on time. Personal Ability to work virtually with project teams across different locations and time zones. Leads by example. Self-reliant. Other skills Highly computer literate and familiar with modern IT and communications technology. Good presentation skills. Combines scientific excellence with ability to make impact in drug discovery and development programs. Ability to manage multiple client project timelines and deliverables simultaneously. Role (depending on experience) Overall responsibility for project delivery of quality QSP solutions on time. Provide hands-on technical support for model building when required. Work with clients to ensure they receive the expected added value. Work with the consortium/ consulting teams to ensure optimal deployment of resources. Work with Certara QSP line management to deliver optimum solutions. Provide general expert technical input across Certara QSP portfolio. Mentor other Certara QSP staff. Qualifications Postdoctoral experience in systems modelling for drug discovery/ development teams. PhD (or equivalent) in life sciences, engineering, computer sciences, mathematics physics or equivalent. Good understanding of PKPD, pharmacology and biology and its application in drug discovery and development. Very familiar and outstanding hands-on expertise with Matlab, Neuron or other similar modelling software. Strong publication record (commensurate with level of experience). Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Feb 14, 2025
Full time
Overview About Certara Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. The Certara Quantitative Systems Pharmacology (QSP) group is a global organization focused on the impactful application of QSP and mechanistic PKPD modeling and simulation in drug discovery and development. We are leading several first-of-its-kind QSP Consortia with more than 10 global pharmaceutical companies and have a rapidly expanding consultancy portfolio. Our QSP scientists work in close collaboration with other Certara staff and clients to generate and use state-of-the-art mechanistic models for decision making in pharmaceutical R&D. The models are designed in close dialogue with clients and developed with a view to creating user-friendly tools that will inform drug development programs from discovery to regulatory filing. We have unique capability to seamlessly integrate bespoke QSP models into the Simcyp physiologically based pharmacokinetic (PBPK) platform. Besides our well-established leadership in applied QSP approaches in Immunology and Immuno-Oncology, we are now also the leading provider of QSP approaches in neuro-degenerative diseases through Certara's recent acquisition of the In Silico Biosciences modelling platform. We are seeking highly motivated and talented QSP modelling experts at all levels, who share our passion for using quantitative approaches to understand and impact complex drug discovery and development questions. Positions are available at various levels of experience across our global locations and for flexible, home-based roles. Responsibilities Technical Postdoctoral experience in systems modelling for drug discovery/ development teams. PhD (or equivalent) in life sciences, engineering, computer sciences, mathematics physics or equivalent. Good understanding of PKPD, pharmacology and biology and its application in drug discovery and development. Very familiar and outstanding hands-on expertise with Matlab, Neuron or other similar modelling software. Strong publication record (commensurate with level of experience). Team working Excellent interpersonal skills. Skilled and experienced at facilitating a multi-disciplinary team to work together on a complex project. Ability to communicate with all stakeholders clearly and efficiently. Organised and with track record of delivering quality results on time. Personal Ability to work virtually with project teams across different locations and time zones. Leads by example. Self-reliant. Other skills Highly computer literate and familiar with modern IT and communications technology. Good presentation skills. Combines scientific excellence with ability to make impact in drug discovery and development programs. Ability to manage multiple client project timelines and deliverables simultaneously. Role (depending on experience) Overall responsibility for project delivery of quality QSP solutions on time. Provide hands-on technical support for model building when required. Work with clients to ensure they receive the expected added value. Work with the consortium/ consulting teams to ensure optimal deployment of resources. Work with Certara QSP line management to deliver optimum solutions. Provide general expert technical input across Certara QSP portfolio. Mentor other Certara QSP staff. Qualifications Postdoctoral experience in systems modelling for drug discovery/ development teams. PhD (or equivalent) in life sciences, engineering, computer sciences, mathematics physics or equivalent. Good understanding of PKPD, pharmacology and biology and its application in drug discovery and development. Very familiar and outstanding hands-on expertise with Matlab, Neuron or other similar modelling software. Strong publication record (commensurate with level of experience). Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.