Lead and shape statistical programming strategy for a portfolio of products, primarily in oncology, ensuring all clinical data outputs meet global regulatory expectations. Oversee end-to-end programming deliverables, from study execution to submission support, while driving consistency with functional standards and industry best practices.
Key Responsibilities
- Direct global statistical programming activities for assigned therapeutic areas, ensuring timely and accurate delivery of clinical study outputs
- Develop and implement programming strategies aligned with evolving regulatory and operational requirements
- Manage project timelines, identify risks, and resolve issues impacting programming workflows
- Oversee relationships with Functional Service Providers (FSPs), ensuring effective resourcing and performance alignment with product goals
- Contribute to resource planning, budgeting, and staffing allocation within the programming function
- Monitor team productivity and adapt staffing deployment based on project priorities
- Lead or support cross-functional initiatives to enhance programming processes and systems
- Support internal and external audits by preparing documentation and responding to findings
- Develop, review, and maintain global policies, SOPs, and controlled documents related to statistical programming
- Provide hands-on programming support when necessary and mentor team members in technical and professional growth
- Contribute to individual career development plans and foster a culture of continuous learning
Qualifications
Eligible candidates will hold a doctorate with two years of pharmaceutical statistical programming experience, or a master’s with six years, a bachelor’s with eight years, an associate’s with ten years, or a high school diploma with twelve years in the field. Expertise in SAS Graph, SAS STAT, SAS Macro, SQL, and familiarity with R is expected. Prior experience with regulatory submissions, clinical data compliance, and software development life cycles strengthens candidacy. Demonstrated leadership in managing programming teams, guiding process improvements, and collaborating across global, multicultural teams is highly valued. Strong communication skills and the ability to manage complex programming tasks independently are essential.
Work Environment & Culture
This role operates in a hybrid work model, supporting flexible arrangements including remote work where feasible. The organization emphasizes patient-focused innovation, inclusive collaboration, and support for both professional advancement and personal well-being. Employees benefit from comprehensive medical, dental, and vision coverage; retirement plans with strong company contributions; disability and life insurance; flexible spending accounts; discretionary annual bonuses; stock-based incentives; and generous time-off policies, including company-wide shutdowns. The company maintains a commitment to equal opportunity and provides accommodations for individuals with disabilities upon request.
