Job Description

Overview:
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 our employees! We are a division of Certara and deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables—to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience working on thousands of key drug development projects on behalf of hundreds of biopharma companies, we bring a track record of success and a broad range of expertise to each assignment.

The PKPD Data Manager 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 an MS, BS, or equivalent in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields with a minimum 3 to 5 years’ experience and expertise in PK analysis, data management, reporting writing, and regulatory requirements.

Certara is a growing company that provides a novel 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 wellbeing of our employees is a priority at Certara, and that is why we support the most important aspects of their lives:

• Financial – competitive pay, incentives, retirement plans, income security programs
• Health and Wellness – comprehensive benefit package, wellness programs, healthy lifestyle office environments
• Work/Life –unlimited paid time off and an employee assistance program
• Growth & Development – performance driven environment
• Community Impact – volunteering opportunities, matching gifts, charitable contributions

• Write, maintain and develop high quality Programs (R, SAS) to facilitate the construction of PopPK datasets (e.g., NONMEM, Phoenix NLME, clinical datasets, SAS transport files, define.xml)
• Work closely with Pharmacometricians to create precise data specifications and offer programming support for analyses, such as population PK models, PK/PD analyses, exposure-response analyses, clinical trial simulations, and other quantitative analyses
• Perform quality control (QC) review of data programs
• Create CDISC-compliant SDTM, ADAM and SEND datasets (e.g. PC, PP, ADPC etc)
• Convert non-standard datasets into known standards
• Generate report tables, listings, and figures for regulatory submissions
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  Create Define packages and Reviewers Guides.
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  Collaborate with team members to develop Data and QC processes and automation for Pharmacometric data management activities
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  Assist in the review of final reports for regulatory submissions with respect to data management activities
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  Provide training to junior staff and help to develop data programming skills and efficiencies
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  Ensure that work is delivered on time and within budget in order to achieve business results
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  Support and collaborate with project teams of scientific professionals in pharmaceutical and biotechnology companies involved in the development of small and large molecule drugs

• M.S., or Ph.D. (or equivalent) in Statistics, Mathematics, or a related discipline.
• Minimum of 10 years of experience in writing SAS/R codes for Pharmacometric analyses in support of various phases of drug development.
• Advanced training in R/SAS programming is strongly preferred.
• Must be an expert in SAS dataset construction, with a strong preference for familiarity with PK and PKPD datasets, 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.
• Advanced statistical analysis and data mining software (such as SAS or R) skills.
• Ability to independently develop datasets which require minimal modifications upon peer or supervisory review, and to perform analyses with little or no supervisory review.
• Excellent English writing, editing, verbal communication, and interpersonal skills.