United States onlyThe Director, Statistical Programming will support and oversee all statistical and clinical programming activities from all development programs and is responsible for planning, monitoring, organizing and reviewing activities of statistical programming team, to ensure analyses are delivered on time, on budget with rigor and quality, by working with Biostatistics, Clinical Data Management, and other functional stakeholders. The position serves as an in-house expert for statistical programing and data standards, and assists the Head of Biometrics and team to develop functional strategies and drives the development and continuous improvement of departmental procedures, training and standards.
Title: Director, Statistical Programming
Reporting to: VP, Biometrics
Location: Remote
Responsibilities
- Leadership and Management:
- Lead and manage statistical programming activities for clinical studies, ensuring high-quality deliverables and adherence to established timelines. Allocate resources effectively and promote resource sharing across programs to meet departmental and organizational goals.
- Cross-Functional Collaboration:
- Collaborate with biostatisticians, data managers, and cross-functional teams to define programming strategies and requirements, ensuring alignment with overall clinical and regulatory objectives.
- Programming and Data Development:
- Develop, validate, and maintain analysis datasets in compliance with CDISC standards, as well as tables, listings, and figures (TLFs) in accordance with regulatory guidelines and internal standards.
- Statistical Analysis Planning:
- Review Statistical Analysis Plans (SAPs) to provide feedback, technical input, and strategic recommendations for successful execution.
- Regulatory Submissions:
- Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), ensuring compliance with eCTD and electronic submission standards.
- Process Optimization:
- Build and maintain software-agnostic solutions and macros to automate repetitive tasks and improve programming efficiency.
- Team Development:
- Manage, mentor, and guide junior programmers, fostering their professional growth and ensuring consistent quality across deliverables.
- Continuous Improvement:
- Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis to enhance team capabilities and process efficiency.
Qualifications
- MS degree in Statistics, Computer Science, Mathematics, or a related field
- At least 12 years of experience in the pharmaceutical industry; direct supervisory experience and successful submission experience strongly preferred
- Thorough understanding of ICH Guidelines, relevant regulatory requirements, and CDISC standards
- Familiarity with the expectations of regulatory agencies such as the FDA and EMA
- Direct experience with NDA/BLA or other regulatory filings, including ISS or ISE
- Demonstrated experience in departmental resource allocation
- Ability to work effectively and efficiently both independently and as part of a cross-functional team
- Strong attention to detail and awareness to escalate issues appropriately
The salary range for this position is from $215,000 to 235,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan
