Senior Statistical Programmer

Responsibilities

• 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.
• Gathers and interprets user requirements for programming requests, retrieves required data, transforms data into analysis/modeling datasets, and develops tables, listings and figures according to statistical/modeling analysis plan.
• Pairs with stakeholders to solve problems; reduces the amount of programming tasks being completed by stakeholders to facilitate an increase in efficiency and compliance for the analyses.
• Writes programs to analyze data with statistical methods which are not currently available through commercial software packages.
• Serves as a key collaborator with statisticians, pharmacokinetic (PK) modelers, and other project stakeholders.

Requirements

• 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.
• Comprehends 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.
• Completes statistical programming deliverables through the use of global outsource partner programming staff.
• Active in professional societies.
• BARDS2020 eligible.