Senior Scientist, Statistical Programming, Late-Stage Oncology (Remote)

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

• Support statistical programming activities for late-stage drug/vaccine clinical development projects, including leadership of one or more projects.
• Develop and execute statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures) for individual clinical trials, worldwide regulatory application submissions, and post-marketing support.
• Design and maintain statistical datasets supporting multiple stakeholder groups, including clinical development, outcomes research, and safety evaluation.
• Serve as the statistical programming point of contact and knowledge holder for assigned projects throughout the entire product lifecycle.
• Collaborate with statistics and other project stakeholders to ensure efficient execution of project plans with timely, high-quality deliverables.
• Effective analysis and report programming development and validation using global and therapeutic area (TA) standards, following departmental SOPs and good programming practices.
• Maintain and manage a project plan, including resource forecasting.
• Coordinate activities of a global programming team, including outsource provider staff.
• Participate in departmental strategic initiative teams.

Requirements

• 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, or MS in the same fields plus a minimum of 3 years SAS programming experience in a clinical trial environment.
• Effective interpersonal skills and ability to negotiate and collaborate.
• Strong written, oral, and presentation skills.
• Experience developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Project leadership; ability to complete tasks independently and collaborate with key stakeholders.
• Significant expertise in SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, SAS/GRAPH, systems, and database expertise.
• Ability to design and develop complex programming algorithms.
• Understanding of statistical terminology and concepts; ability to comprehend analysis plans describing methodology to be programmed.
• Familiarity with clinical data management concepts.
• Experience with CDISC and ADaM standards.
• Experience ensuring process compliance and deliverable quality.
• Strategic thinking—ability to turn strategy into tactical activities and design statistical databases with the end in mind, optimizing analysis and reporting while leveraging departmental standards and industry best practices.
• Ability to anticipate stakeholder requirements.

Preferred Skills

• Demonstrated experience with advanced programming languages such as R (including Shiny) and/or Python.
• Familiarity with the application of Generative AI and emerging technologies within statistical programming pipelines.
• Demonstrated success in assuring 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 development of electronic submission deliverables.
• Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers, and mentoring.
• Ability and interest to work across cultures and geographies.
• Experience completing statistical programming deliverables using global outsource partner programming staff.
• Experience developing and managing a project plan using Microsoft Project or similar tools.
• Active involvement in professional societies.
• Experience in process improvement.
• Demonstrated proficiency in steering statistical programming deliverables post-DBL (database lock), ensuring data integrity of unblinded data.
• Strong capability to operate efficiently in high-pressure environments, swiftly addressing emergent post-DBL challenges through decisive stakeholder communication and rapid technical resolution.

Pay

The salary range for this role is $117,000.00 - $184,200.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Comprehensive medical, dental, vision, and other insurance benefits for employee and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate, and sick days.

VISA sponsorship is available for this role. Travel requirements are approximately 10%. Flexible work arrangements, including remote options, may be available.