Sr. Manager/Associate Director, Statistical Programming

Fortvita Biologics; Palo Alto (CA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Fortvita Biologics is seeking a Sr. Manager/Associate Director of Statistical Programming to lead hands-on programming activities across Phase I–III.

This role delivers analysis datasets, tables, figures, and listings, while guiding CRO/vendor programming and ensuring submission-ready outputs for a global portfolio. The ideal candidate has 5+ years at Senior Manager level or 7+ years at AD level in statistical programming, with expert SAS and CDISC SDTM/ADaM skills.

Qualifications

• Expert knowledge of SAS, CDISC (SDTM/ADaM), and regulatory submissions.
• Experience supporting Phase I–III global clinical trials.
• Strong leadership and cross-functional collaboration across Biostatistics, Data Management, Clinical and Regulatory.

Responsibilities

• Lead statistical programming activities across development programs.
• Oversee SDTM/ADaM, Tables, Listings, and Figures (TLFs) and interim analyses.
• Support regulatory submissions (IND, NDA, BLA, MAA) and audit readiness.
• Develop and maintain scalable programming infrastructure and reusable code libraries.
• Ensure GXP compliance with ICH-GCP, 21 CFR Part 11, and global regulations.
• Partner with cross-functional teams to drive quality and efficiency.
• Drive KPI tracking, governance, and continuous improvement.

Skills

SAS

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Job description

JOB TITLE: Sr. Mgr/AD, Statistical Programming

LOCATION:

Remote (U.S.-based) - CA, CO, CT, FL, IL, IN, MA, MD, MN, MT, NH, NJ, NY, NC, PA, RI, TX, UT, VA, WA

Preference is Hybrid – Palo Alto Office

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

The Sr. Manager/Associate Director, Statistical Programming serves as a hands‑on technical lead for statistical programming activities across Phase I–III clinical studies. This role delivers and reviews analysis datasets, tables, figures, and listings; contributes to programming standards and infrastructure; supports regulatory submission deliverables; provides technical oversight of CRO and vendor programming; and partners cross‑functionally with Biostatistics, Data Management, Clinical, and Regulatory to ensure high‑quality, submission‑ready outputs for 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.
• 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

• Expert knowledge of SAS, CDISC (SDTM/ADaM), and regulatory submissions.
• Experience supporting Phase I–III global clinical trials.
• Years of experience:

-AD level: 7+ years of statistical programming experience.

-Sr. Manager level: 5+ years of statistical programming experience.

PREFERRED QUALIFICATIONS

• Experience in oncology or immunology.
• Experience in a small or mid‑sized biotechnology company.
• Experience building a statistical programming function.
• Professional proficiency in Mandarin and English is required.

COMPETENCIES/CORE SKILLS

• Strategic leadership with hands‑on execution.
• Strong analytical and communication skills.
• Commitment to quality and continuous improvement.

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 [e-mail]. 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.