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

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

Summary

Responsibilities:

This position provides high quality statistical programming deliverables for global stakeholders in Early Development Statistics and PK/PD Modeling and Simulation spanning all our Company's therapeutic areas except oncology.  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 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

Skills

Education and Minimum Requirement:

• 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

Department Required Skills and Experience:

• 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

Position Specific Required Skills and Experience:

• 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.

Preferred Skills and Experience:

• 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

BARDS2020

eligibleforERP

SPjobs

VETJOBS

EBRG

Required Skills:

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

Preferred Skills:

NONMEM, Pharmacokinetic Modeling, PKPD Modeling, Python (Programming Language), R Programming, Translational Pharmacokinetics and Pharmacodynamics (PKPD)

Current Employees apply HERE

Current Contingent Workers apply HERE