Sr. Scientist, Stat. Programming - Late-Stage; Non-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.

• Effective analysis and report programming development and validation utilizing global and therapeutic area 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 team

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 5 years SAS programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 3 years SAS programming experience in a clinical trial environment

• 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

• 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 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

• Experience using R for statistical modeling, data analysis, and visualization
• Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life‑cycle (SDLC)
• US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables
• Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor
• Ability and interest to work across cultures and geographies
• Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
• Developing and managing a project plan using Microsoft Project or similar package
• Active in professional societies
• Experience in process improvement

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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We offer a comprehensive package of benefits,…