Associate Principal Scientist, Statistical Programming- Hybrid

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our 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.

Position Description:

Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to assist decision making in clinical trials.

This position supports statistical programming activities for multiple and/or late stage drug clinical development 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 Responsibilities:

• Effective analysis and report programming development and validation utilizing global and therapeutic areas standards and following departmental standard operating procedures (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.

Position Qualifications:

Education Minimum Requirements:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9-12 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.

Required Experience and Skills:

• Excellent interpersonal skills and ability to negotiate and partner effectively.

• Excellent written, oral, and presentation skills.

• Broad knowledge and significant experience in developing analysis and reporting deliverables for research & development (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.

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

•  Leading large and/or complex statistical programming projects that include coordinating the activities of a programming team.

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

• Designs and develops complex programming algorithms.

• Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts.

• Familiarity with clinical data management concepts.

• Hands on experience in CDISC and ADaM standards.

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

• Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.

• Ability to anticipate stakeholder needs.

Preferred Experience and Skills:

• Strong working knowledge of reporting processes standard operating procedures (SOPs) and software development life-cycle (SDLC).

• Providing technical and/or