Principal Scientist- Statistical Programmer - Oncology- Hybrid

Job Description

This position focuses on strategic activities impacting late-stage development therapeutic area (TA) projects to the direct benefit of project teams and the Biostatistics organization.

The position is a key collaborator with internal and external stakeholders including Statistics, Clinical Research, Regulatory, Observational Research, Clinical Safety and PK/PD Modeling and Simulation organizations.

Primary Activities:

• Address operational challenges that require strategic solutions, resulting in improved Clinical Study Report and filing completion timelines worldwide.

• Lead development of therapeutic areas- specific standard Tables, Listings, Figures (TLF) libraries 

• Facilitate global adoption of therapeutic areas standards and programming best practices.

• Contribute to strategic solutions in support of internal stakeholder groups including the Outcomes Research and Clinical Safety organizations.

• Lead and actively contribute to departmental strategic initiative project teams.

Education and Minimum Requirement:

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12 years SAS programming experience in a clinical trial environment.

MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 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

• Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for Research & Development projects (data, analyses, tables, graphics, listings)

• Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs effort others; ability to engage key stakeholders.

Position Specific Required Skills and Experience:

• Expertise in SAS and clinical trial programming

• Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and therapeutic area standards and according to quality, compliance and timeliness requirements.

• US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.

• Designs and develops complex programming algorithms.

• Familiarity with statistical analysis methods, terminology and concepts.

• Superior experience as a statistical programmer

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