Lead the strategic direction and execution of statistical programming activities for a portfolio of global clinical development programs, primarily in oncology and other therapeutic areas. Oversee end-to-end delivery of study outputs, ensuring accuracy, compliance, and alignment with international regulatory standards.
What You'll Do
- Direct statistical programming deliverables for global clinical trials, supporting regulatory submissions and data analysis timelines.
- Define and implement programming standards, tools, and processes aligned with evolving industry and regulatory expectations.
- Manage project timelines, identify risks, and resolve operational challenges to maintain progress and quality.
- Oversee relationships with external programming vendors, ensuring effective resourcing and performance accountability.
- Contribute to resource planning, budget forecasting, and staffing allocation for programming teams.
- Support internal and regulatory audits by preparing documentation and ensuring compliance with data integrity standards.
- Develop and maintain global policies, standard operating procedures, and controlled documents for programming functions.
- Provide technical guidance and hands-on programming support when needed.
- Lead process improvement initiatives and collaborate with cross-functional teams to enhance efficiency.
- Coach, mentor, and support professional growth of programming staff, including input into performance and career development plans.
Requirements
- Doctorate with 2 years of pharmaceutical statistical programming experience
- OR Master’s degree with 6 years of relevant experience
- OR Bachelor’s degree with 8 years of experience
- OR Associate’s degree with 10 years of experience
- OR High school diploma / GED with 12 years of experience in pharmaceutical statistical programming
Preferred Qualifications
- Extensive experience with SAS Graph, SAS STAT, SAS Macro, and SQL
- Proficiency in R programming and advanced statistical analysis techniques
- Direct involvement in regulatory submissions and interactions
- Strong background in data quality, validation, and compliance processes
- Experience in software development lifecycle activities, including requirements gathering and test planning
- Proven ability to lead programming teams across multiple studies in a global, cross-cultural environment
- Project management and staff development leadership experience
- Excellent communication skills, both written and verbal
- Ability to execute complex programming tasks with precision and independence
Benefits
- Retirement and Savings Plan with significant company contributions
- Medical, dental, and vision insurance coverage
- Life and disability insurance options
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Generous time-off policies, including bi-annual company-wide shutdowns
- Flexible work models, including remote work where feasible
