Senior Statistical Programmer- Analysis & Reporting - Hybrid

Job Description

Responsibilities:

This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and global PK/PD modeling and simulation stakeholders spanning both early and late in all our Company therapeutic areas except early oncology.  The senior statistical programmer will gather and interpret user requirements for analysis and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into analysis/modeling datasets, and develop tables and figures according to statistical/modeling analysis plan. The senior programmer will partner with stakeholders to solve problems; reduce the amount of programming task being completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses.  The senior programmer will also write programs to analyze data with statistical methods which are not currently available through commercial software packages. The senior programmer will be a key collaborator with statisticians, modelers, and colleagues in other related function areas.

Primary Activities:

• 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

• Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses

• Pre-process, filter, and manipulate complex data for the analyses of molecular biomarker data, imaging data, and external data other than traditional laboratory data

Education and Minimum Requirement:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS 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 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

Position Specific Required Skills and Experience:

• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH

• Experience with at least one other software than SAS (e.g., R, Python, NonMem)

• 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.

• Experience in CDISC SDTM and ADaM standards

• 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

• 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).

Preferred Skills and Experience:

• Familiarity with clinical pharmacology concepts and pharmacokinetics concepts

• 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

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