Pkpd Programmer

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.

**About our Integrated Drug Development Biostatistics Department**

**Responsibilities**:
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).

**Responsibilities**
- 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
- Create Define packages and Reviewers Guides.
- Collaborate with team members to develop Data and QC processes and automation for Pharmacometric data management activities
- Assist in the review of final reports for regulatory submissions with respect to data management activities
- Provide training to junior staff and help to develop data programming skills and efficiencies
- Ensure that work is delivered on time and within budget in order to achieve business results
- Support and collaborate with project teams of scientific professionals in pharmaceutical and biotechnology companies involved in the development of small and large molecule drugs

Qualifications:

- M.S., or Ph.D. (or equivalent) in Statistics, Mathematics, or a related discipline.
- Minimum of 5 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.

**Skills & Abilities**
- 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 mínimal 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.