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Associate Principal Scientist Statistical Programming- Oncology, PKPD- Hybrid
Merck & Co. - North Wales, PA
posted 2 months ago
About the position
The Associate Principal Scientist in Statistical Programming for Oncology and PKPD is responsible for delivering high-quality statistical programming analysis and reporting for global pharmacokinetic modeling and simulation projects. This role involves gathering user requirements, transforming data into analysis-ready datasets, and collaborating with modelers and statisticians to ensure efficient project execution. The position also includes leadership responsibilities in data stewardship and the development of programming standards.
Responsibilities
- Programmatically synthesize clinical/preclinical data into analysis-ready structures from varied data sources.
- Create modeling-ready datasets by integrating PK, ADA, PD, and covariate data.
- Produce tables and graphics for inclusion in study reports and regulatory submissions.
- Ensure programmatic traceability from data source to modeling result.
- Support the development of programming standards to enable efficient and high-quality production of programming deliverables.
- Produce SAS transport files and associated documentation for regulatory submissions.
- Represent statistical programming on process improvement activities.
Requirements
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment.
- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment.
- Excellent interpersonal skills and ability to negotiate and collaborate effectively.
- Excellent written, oral, and presentation skills.
- Broad knowledge and significant experience in developing analysis and reporting deliverables for Research and Development projects.
- Strong project management skills; leadership at a program level.
Nice-to-haves
- Familiarity with pharmacokinetics modeling and simulation datasets and analyses.
- Experience with at least one other software than SAS (e.g., R, Splus, NonMem).
- Good working knowledge of reporting processes (SOPS) and software development life cycle (SDLC).
- Utilizes and contributes to the development of standard departmental SAS macros.
- Ability and interest to work across cultures and geographies.
Benefits
- Health insurance
- Paid holidays
- Retirement plan
- Visa sponsorship
