Senior Statistical Programmer, Early Stage Development and Pharmacokinetic/Pharmacodynamic Modeling and Simulation (Hybrid)

MSD•North Wales, PA

1d•Hybrid

About The Position

This position is within BARDS (Biostatistics and Research Decision Sciences), a department in the company's Research and Development division. Quantitative scientists in BARDS apply state-of-the-art scientific methodologies and tools to support the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines. The Senior Statistical Programmer will provide high-quality statistical programming deliverables for global stakeholders in Early Development Statistics and PK/PD Modeling and Simulation across all therapeutic areas except oncology. Key responsibilities include gathering and interpreting user requirements, retrieving and transforming data into analysis/modeling datasets, and developing tables, listings, and figures according to statistical/modeling analysis plans. The role involves significant collaboration with statisticians, modelers, and colleagues in other functional areas.

Requirements

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment OR MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment
Excellent communication (oral, written) skills, interpersonal skills and ability to negotiate and collaborate effectively
Effective knowledge and experience in developing analysis and reporting deliverables for research and development projects (data, analyses, tables, graphics, listings)
A project leader; completes tasks independently at project level
Programming expertise with clinical endpoint data (efficacy and safety)
Experience in CDISC SDTM and ADaM standards
Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
Designs and develops complex programming algorithms
Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts
Implements statistical methods not currently available through commercial software packages
Accountability
Applied Engineering
Clinical Trials
Computer Science
Data Analysis
Data Management
Data Modeling
Mechatronics
Numerical Analysis
SAS Graphs
SAS Language
Software Development
Stakeholder Relationship Management
Statistical Programming
Waterfall Model

Nice To Haves

Programming expertise with pharmacokinetic data (raw concentration data, derived PK parameters)
Familiarity with clinical pharmacology concepts and pharmacokinetics concepts
Experience with at least one other software than SAS (e.g., R, Python, 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
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
Active in professional societies
NONMEM
Pharmacokinetic Modeling
PKPD Modeling
Python (Programming Language)
R Programming
Translational Pharmacokinetics and Pharmacodynamics (PKPD)

Responsibilities

Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation
Ensure programmatic traceability from data source to analysis/modeling result
Support the development of programming standards to enable efficient and high-quality production of programming deliverables