Director, Statistical Programming

Position Summary

The Statistical Programming Director is responsible for driving the execution and oversight of the related activities across clinical studies, ensuring high-quality, compliant, and timely deliverables. This Director leads the development and implementation of CDISC-compliant datasets (SDTM, ADaM) and tables, figures, and listings (TFLs), while supporting both planned and ad-hoc analyses to address evolving clinical and business needs.

Primary Responsibilities

• Lead statistical programming efforts for clinical studies to ensure clarity, integrity, and compliance with internal and external standards
• Lead the execution of ad-hoc and post-hoc analyses to support emerging clinical questions, publications, and internal decision-making
• Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables
• Conduct independent validation and quality checks of statistical programming deliverables from CROs
• Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner
• Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines
• Deliver on other related projects as assigned.

Qualifications

• Education and Certification
• PhD in Statistics/Biostatistics
• Work Experience
• 12+ years of experience in biotech, pharma or related industries
• Hands-on experience with programming for clinical development
• Direct experience with regulatory submissions (NDAs, BLAs, and other filings) with experience in ISS/ISE
• Advance expertise with SAS programming and comprehensive knowledge of CDISC standards
• Working knowledge of ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)
• Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables
• Proficiency in SAS and/or R
• Skills and Key Success Factors
• Entrepreneurship spirit with a passion to build, learn and evolve with the team
• Highly organized and detail oriented with a passion to deliver quality results
• Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
• Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
• Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
• Evidence of "hands-on" experience and expertise
• Proven and successful track record as a team-player and collaborator in small working environments
• Highest levels of professionalism, confidence, personal values and ethical standards

Compensation

• Base Salary Range: $230K - $245K, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: up to 20% of Base Salary, contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.