Responsibilities
This position provides high quality statistical programming deliverables for global stakeholders in Early Development Statistics and/or PK/PD Modeling and Simulation spanning all our Company's therapeutic areas. The senior statistical programmer will gather and interpret user requirements for programming requests, retrieve required data, transform data into analysis/modeling datasets, and develop tables, listings and figures according to statistical/modeling analysis plan. The senior programmer will partner with stakeholders to solve problems; reduce the amount of programming tasks being completed by stakeholders to facilitate an increase in efficiency and compliance for the analyses. The senior programmer will also write programs to analyze data with statistical methods which are not currently available through commercial software packages. The programmer will be a key collaborator with statisticians, pharmacokinetic (PK) modelers, and other project stakeholders.
Primary Activities
- 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 / modeling result
- Support the development of programming standards to enable efficient and high quality production of programming deliverables
Education and Minimum Requirement
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS/R programming experience in a clinical trial environment
- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS/R programming experience in a clinical trial environment
Department Required Skills and Experience:
- Effective interpersonal skills and ability to negotiate and collaborate effectively
- Effective written, oral, and presentation skills
- 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 a project level; ability to collaborate with key stakeholders
Specific Required Skills and Experience:
- Experience in CDISC SDTM and ADaM standards
- Significant SAS or R programming experience for data manipulation, analysis and reporting
- 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
- Demonstrated ability to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes
Preferred Skills and Experience:
- Programming expertise with pharmacokinetic data (raw concentration data, derived PK parameters)
- Familiarity with clinical pharmacology concepts and pharmacokinetics concepts
- Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation; programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters)
- 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
