Sr. Scientist, Statistical Programming - Early 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.

Responsibilities:

This position supports statistical programming activities for Early Oncology clinical development projects, Aggregated Safety Analysis and Secondary Publication. 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) for early oncology studies. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, 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.

Primary Activities:

• Effective analysis and report programming development and validation, utilizing global and therapeutic area (TA) standards and following departmental standard operating procedures (SOPs) and good programming practice.

• Maintain and manage a project plan including resource forecasting.

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

• Membership on departmental strategic initiative teams

Education and Minimum Requirement:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS/R programming experience in a clinical trial environment

• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS/R programming experience in a clinical trial environment

Department Required Skills and Experience:

• 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 Required 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 the methodology to be programmed; an understanding of statistical terminology and concepts

• Familiarity with clinical data management concepts

• Experience in CDISC and ADaM standards

• Experience ensuring process compliance and deliverable quality

• 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 requirements

Preferred Skills and Experience:

• Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)

• Oncology clinical trial programming experience is preferred.

• AI/Machine learning experience