Associate Principal 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.

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 all our company therapeutic areas except early oncology.

The Associate Principal 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 Associate Principal 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 Associate Principal Programmer will write programs to analyze data with statistical methods which are not currently available through commercial software packages. The Associate Principal Programmer will be a key collaborator with statisticians, modelers, and colleagues in other related function areas.

Primary Activities:

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

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

• 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

• Maintain and manage a project plan including resource forecasting

• Support the development of programming standards to enable efficient and high-quality production of programming deliverables

• Represent statistical programming on process improvement activities

Education and Minimum Requirement:

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment

MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment

Department Required Skills and Experience:

• Excellent interpersonal skills and ability to negotiate and collaborate effectively

• Excellent written, oral, and presentation skills

• Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)

• Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders

Position Specific Required Skills and Experience:

• 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.

• Experience in CDISC SDTM and ADaM standards

• Demonstrated success in the assurance of deliverable quality and process compliance

• Thrives in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical developmen