Senior Statistical Programmer, Late Stage Development, Oncology (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 supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.

The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.

Primary Activities:

• Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.

• Maintain and manage a project plan including resource forecasting. 

• Coordinate the activities of a global programming team that includes outsource provider staff.

• Membership on departmental strategic initiative teams

Educational Qualifications:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field and at least 5 years SAS programming experience in a clinical trial environment or

• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field and at least 3 years SAS programming experience in a clinical trial environment.

Required Skills:

• 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 R&D projects (data, analyses, tables, graphics, listings)

• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders.

Position Specific Skills and Experience:

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

• Designs and develops complex programming algorithms.

• Ability to comprehend analysis plans which may describe methodology to be programmed, an understanding of statistical …