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

MSD•North Wales, PA
•Hybrid
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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

Benefits

  • annual bonus
  • long-term incentive
  • medical healthcare and other insurance benefits (for employee and family)
  • dental healthcare and other insurance benefits (for employee and family)
  • vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate days
  • sick days

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Number of Employees

5,001-10,000 employees

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Based on current job postings on Teal, the average Statistical Programmer salary in the US is approximately $140,000 per year, with a typical range of $90,000 to $219,000.

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