Dir, Statistical Programming

LOCATION:

Hybrid – Palo Alto, CA

Travel up to 15% required

ABOUT THE COMPANY

Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs. Building on our foundation in oncology, we are expanding into cardiovascular and metabolic diseases, immunology, and ophthalmology, applying our scientific rigor and platform capabilities to areas of growing global health burden. Our expertise covers antibody discovery and engineering, including monoclonal, bispecific, and polyspecific antibodies, as well as antibody-drug conjugates, all supported by development strategies rooted in thoughtful design and agile execution.

Our clinical development footprint covers the U.S., Australia, and key regions across APAC and Europe, including the EU, UK, South Korea, and Japan. With more than 100 professionals across research, development, regulatory, and operations, we bring deep expertise and a global perspective to every program. Guided by our mission to transform research breakthroughs into therapeutic excellence and driven by our vision to improve lives through scientific innovation, we are committed to delivering meaningful impact for patients around the world.

POSITION SUMMARY

Reporting to the Vice President of Biostatistics, the Director of Statistical Programming provides strategic leadership and hands-on oversight of statistical programming across Phase I–III clinical studies. The Director leads programming standards, infrastructure, regulatory deliverables, vendor oversight, and cross-functional collaboration to ensure high-quality, submission-ready outputs supporting Fortvita's global clinical development portfolio.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Statistical Programming Leadership

• Support the Vice President, Biostatistics in executing the statistical programming strategy.

• Lead day-to-day statistical programming activities across development programs.

• Build and mentor a high-performing programming team.

• Establish programming standards, governance, and best practices.

• Support departmental planning and resource forecasting.

Clinical Trial Programming

• Oversee SDTM, ADaM, Tables, Listings, and Figures (TLFs).

• Support interim analyses, database lock, and final study reporting.

• Support integrated analyses (ISS/ISE) where applicable.

Regulatory Submission Support

• Lead programming support for IND, NDA, BLA, and MAA submissions.

• Ensure compliance with FDA, EMA, PMDA, ICH, and CDISC requirements.

Programming Standards & Infrastructure

• Lead the development and maintenance of scalable programming infrastructure for the Biometrics department.

• Maintain programming environments, reusable code libraries, macros, validation frameworks, and automation tools.

• Establish version control, validation standards, and inspection-ready documentation.

• Evaluate emerging technologies that improve programming efficiency and scalability.

Vendor Management

• Oversee statistical programming vendors and FSP partners.

• Establish KPIs, governance, budgets, and quality expectations.

Cross-Functional Collaboration

• Partner with Biostatistics, Clinical Data Management, Clinical Operations, Clinical Development, Regulatory Affairs, Medical Writing, and Quality.

• Provide programming expertise during protocol and SAP development.

Quality & Compliance

• Maintain inspection readiness and support audits and regulatory inspections.

• Ensure compliance with ICH-GCP, 21 CFR Part 11, and global regulations.

Operational Excellence

• Develop KPIs and dashboards.

• Drive continuous improvement and perform other duties as assigned

Other duties as assigned

REQUIRED QUALIFICATIONS

• Bachelor's degree in a quantitative discipline; advanced degree preferred.

• 10 years of statistical programming experience.

• 5 years of leadership experience.

• Expert knowledge of SAS, CDISC (SDTM/ADaM), and regulatory submissions.

• Experience supporting Phase I–III global clinical trials.

PREFERRED QUALIFICATIONS

• Experience in oncology or immunology.
• Experience in a small or mid-sized biotechnology company.
• Experience building a statistical programming function.

COMPETENCIES/CORE SKILLS

• Strategic leadership with hands-on execution.

• Strong analytical and communication skills.

• Vendor management expertise.

• Commitment to quality and continuous improvement.

COMPENSATION

• The base salary range for this position is $220,000.00 to $270,000.00. Actual starting pay is determined based on the candidate's years of relevant experience, educational background, and demonstrated skills.

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

Employment may be contingent upon successful completion of a background check and any other requirements permitted by law.