Director, Biostatistics
Artiva Biotherapeutics•San Diego, CA
•$215,000 - $250,000
About The Position
The Director, Biostatistics will play a key role in supporting clinical development programs at Artiva. This individual will collaborate closely with clinical development and study teams to deliver high-quality statistical support across the portfolio.
Requirements
- Ph.D. or M.S. in Statistics/Biostatistics with a minimum of 8 years (for Ph.D.) or 12 years (for M.S.) of experience in the biotech/pharmaceutical industry as a statistician/biostatistician.
- Strong hands-on experience leading both early- and late-phase clinical studies.
- Ability to work independently and within a team.
- Demonstrated ability to build and maintain strong cross-functional partnerships across the organization.
- Proficiency in SAS and/or R.
Responsibilities
- Provide statistical leadership and strategic input to clinical development plans, clinical trial design, statistical analysis plan, and regulatory interactions.
- Represent Biostatistics function on cross-function teams and work collaboratively with statistical programmers, CDM, ClinOps, Safety, Medical, Regulatory, and CRO across clinical programs, ensuring deliverables meet timelines, quality standards, and submission requirements.
- Prepare detailed Statistical Analysis Plan (SAP) and develop standardized well-presented mock-up displays for Tables, Listings, and Figures (TLFs), and oversee preparation of all TLFs (including review of outputs generated by programmers) for milestone readouts.
- Collaborate with study team over the course of clinical trials to provide statistical input to study conduct, CRF and database development, as well as data collection and cleaning activities.
- Perform statistical analysis, interpret study results, and collaborate with clinical team to produce study reports, publications, and regulatory submissions.
- Review study reports, publications, and regulatory submission documents to ensure accurate and statistically valid interpretation of the study outcomes.
- Ensure study documentation is filed and maintained to the appropriate standard and is audit-ready.
- Manage adherence to company policies, SOPs, and other controlled documents; ensure all statistical activities comply with departmental standards.
- Keep abreast of advancements in science, medicine, statistics, standards, regulatory guidance in drug development including AI technologies
Benefits
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Bonus.ly recognition program
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
