Certara Working alongside smart and driven colleagues, you can help enable superior model-based drug development and regulatory decision-making. From entry-level candidates to seasoned professionals, Certara hires talent across a multitude of business functions. Whether your passion is PKPD, PBPK, pharmacometrics, quantitative systems pharmacology, client support, regulatory writing, software development or sales. Certara operates from its headquarters in Princeton, NJ USA, with additional offices in the US, Canada, Europe and Asia. Learn more at www.certara.com<http://www.certara.com>. Certara Strategic Consulting Now the largest and most comprehensive model-based drug development and strategic pharmacometrics organization, Certara Strategic Consulting brings together the resources of Certara's leading consulting group, Pharsight Consulting Services (PCS) with scientific powerhouse, Quantitative Solutions. Deeply committed to our mission of bringing new, safer therapies to patients, we are scientists working with our clients to advance the discipline of modeling and simulation in drug development.
Certara Strategic Consulting is hiring and looking for a PKPD Data-Manager (Associate Scientist) The PKPD Data-Manager at Certara Strategic Consulting will be a SAS-programmer and consultant in pharmacokinetics, pharmacodynamics data management. The PKPD Data-Manager will be responsible for conducting data-management in support of CSRs and PKPD modeling and clinical outcomes databases for model-based meta-analyses. The PKPD Data Manager may conduct exploratory analyses of PKPD data in support of modeling analyses. In addition, the PKPD Data-manager will conduct quality control and quality assurance activities on datasets and reports, and may participate in company initiatives to improve efficiency of dataset construction, analysis and reporting (e.g. IT, methodology, efficiency, automation, quality). The qualified candidate will have a BS, MSc, PhD, PharmD, or equivalent in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields with a minimum 1- 5 years experience and expertise in PK analysis, data management, reporting writing, and regulatory requirements. Skills & Abilities * Is an expert in SAS dataset construction, with a strong preference for familiarity with PK and PKPD datasets. In addition, R skills are a plus. * General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology is preferred. * Proficiency in performing PK and statistical analysis using software (e.g., WinNonlin, Phoenix, AutoPilot and SAS, R) is preferred. * Entry level developing PK(PD) modeling is a plus. * Accuracy and a sense of urgency are key in delivering high quality on time. * Ability to support and coordinate multiple projects as requested. * Strong collaborative skills, team player mentality. * Excellent verbal and written communications skills in English. Working at Certara Strategic Consulting The Associate Scientist/PKPD Data-manager will work closely in teams with other Associates, (Expert) modelers and drug development consultants supporting projects for Certara's clients. The PKPD Data-Manager will have the ability to work on a variety of therapeutic indications and data types. Personal development is not only provided, it is expected. Certara Strategic Consulting is the largest pharmacometric organization in the world and assures that various career pathways are offered to match the ambition and personal interests of their consultants. Consulting allows for an optimal work-life balance. We have a preference for working together through office-based locations, but partially working from home and part-time assignments are feasible. The current position is specifically for our offices in Breda or Oss, The Netherlands. For inquiries for this position please send your resume and brief motivation to admi...@wequantify.com<mailto:admi...@wequantify.com> or call +31 088 101 2450. Thomas Kerbusch, SVP EU, Certara Strategic Consulting
