Scientist - Pharmacometrics

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 Scientist may conduct any or multiple of the following activities as a billable consultant in the areas of PK and data management.

• Associate PK tasks such as NCA, creation of TFL, authoring of CSR PK sections, ADA summaries.
• Performs noncompartmental analyses (NCA), creation of tables, figures and listings (TFL), authoring of pharmacokinetic (PK) sections in Clinical Study Report, Regulatory Modules, PK analysis plans and ADA summaries.
• Responsible for developing work plans by planning and budgeting work associated with the requested PK or PK/PD analysis and subsequent reporting.
• Provides internal training to associates.
• Provides input to Certara R&D in order to optimize software tools and streamline PK/PD analyses.
• Conducts data-management in support of CSRs and modeling.
• Construct datasets and/or databases in support of PK modeling or model-based meta analyses (Trial Specialist).
• Conducts quality control and quality assurance activities on datasets and reports.
• May participate in company initiatives to improve efficiency of dataset construction, analysis and reports (e.g. IT, methodology, efficiency, automation, quality).

• BS, MSc, PhD, PharmD, or equivalent in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields.
• Minimum 1- 5 years' experience and expertise in PK analysis, data management, reporting writing, and regulatory requirements.
• Proficiency in performing PK and statistical analysis using software (e.g., WinNonlin), and optimally statistical analysis using software (SAS/R).
• Proficiency in performing PK using software (e.g. WinNonlin, Phoenix WinNonlin, AutoPilot) or is an expert in dataset construction (e.g. R, S-plus, SAS).
• Able to work under minimal supervision and make connections across projects.
• Able to take responsibility for executing deliverables according to internal procedures.
• Solid communication skills; able to effectively communicate with internal team and able to represent Certara.
• Informed about current knowledge developments in their area of expertise and actively acquires new skills to keep up to date demonstrating an interest for continuous improvement.
• Capable to respond to changing environment.
• Applies innovative approaches to day-to-day work.

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.