Senior Statistical Programmer

MSD•North Wales, PA
•$117,000 - $184,200•Hybrid

About The Position

The Senior Statistical Programmer provides high-quality statistical programming deliverables for global stakeholders in Early Development Statistics and/or PK/PD Modeling and Simulation across the company's therapeutic areas. The role gathers and interprets user requirements, retrieves and transforms data into analysis and modeling datasets, and develops tables, listings, and figures according to statistical or modeling analysis plans. The programmer collaborates with statisticians, PK modelers, and other stakeholders to solve problems and improve efficiency and compliance. The role also develops programs to analyze data using statistical methods not available through commercial software packages. The position supports exploratory and unplanned analyses, regulatory submission programming, and programmatic traceability from source data through analysis or modeling results. It also contributes to programming standards and may work with global outsource partner programming staff. The role is based in North Wales, Pennsylvania, with a hybrid work arrangement and 10% travel. Domestic relocation is listed, and visa sponsorship is available.

Requirements

  • BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or a related field plus 5–9 years of SAS/R programming experience in a clinical trial environment; or an MS in one of these fields plus 3–7 years of SAS/R programming experience in a clinical trial environment.
  • Effective interpersonal skills and ability to negotiate and collaborate effectively.
  • Effective written, oral, and presentation skills.
  • Knowledge and experience developing analysis and reporting deliverables for research and development projects, including data, analyses, tables, graphics, and listings.
  • Ability to lead projects, complete tasks independently at a project level, and collaborate with key stakeholders.
  • Experience with CDISC SDTM and ADaM standards.
  • Significant SAS or R programming experience for data manipulation, analysis, and reporting.
  • Ability to design and develop complex programming algorithms.
  • Ability to comprehend analysis plans and statistical methodology, understand statistical terminology and concepts, and implement methods not available through commercial software packages.
  • Demonstrated ability to work in an exploratory environment with non-standard data in a variety of formats and minimal requirements.
  • Knowledge of pharmaceutical development processes.

Nice To Haves

  • Programming expertise with pharmacokinetic data, including raw concentration data and derived PK parameters.
  • Familiarity with clinical pharmacology and pharmacokinetics concepts.
  • Experience efficiently manipulating very large databases, including complex preprocessing, filtering, and manipulation.
  • Programming expertise with clinical endpoint data, including efficacy and safety data.
  • Experience with at least one software package other than SAS, such as R, Python, or NonMem.
  • Good working knowledge of reporting processes (SOPs) and the software development life cycle (SDLC).
  • Experience using and contributing to the development of standard departmental SAS macros.
  • Ability and interest to work across cultures and geographies.
  • Active participation in professional societies.

Responsibilities

  • Programmatically develop, validate, and maintain complex datasets, tables, listings, and figures.
  • Provide technical consultation and analytical support to statisticians and PK modelers for exploratory and unplanned statistical analyses.
  • Prepare compliant programming code for regulatory submissions, including analysis datasets, tables, listings, figures, and associated documentation.
  • Ensure programmatic traceability from data source to analysis or modeling result.
  • Support development of programming standards to enable efficient, high-quality production of programming deliverables.
  • Gather and interpret user requirements for programming requests; retrieve and transform data into analysis and modeling datasets.
  • Develop programs to analyze data using statistical methods not currently available through commercial software packages.
  • Collaborate with statisticians, PK modelers, and other project stakeholders to solve problems and improve efficiency and compliance.
  • Complete statistical programming deliverables through the use of global outsource partner programming staff.

Benefits

  • Medical, dental, and vision healthcare and other insurance benefits for employees and families.
  • Retirement benefits, including 401(k).
  • Paid holidays.
  • Vacation.
  • Compassionate and sick days.
  • Eligible for annual bonus and long-term incentive, if applicable.
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