Director, Biostatistics
Artiva Biotherapeutics
San Diego, CA
Science / R&D / Research, Information Technology, Analyst
About Artiva:
We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.
For more information, visit www.artivabio.com.
Job Summary:
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.
Duties/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
Requirements:
Base Salary: $ 215,000- $250,000. Exact compensation may vary based on level, skills and experience.
We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.
For more information, visit www.artivabio.com.
Job Summary:
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.
Duties/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
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.
- A beautiful facility
- An entrepreneurial, highly collaborative, and innovative environment
- Comprehensive benefits, including:
- 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
- Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
Base Salary: $ 215,000- $250,000. Exact compensation may vary based on level, skills and experience.
About the company
Company website•Biotechnology Research and Pharmaceutical Manufacturing
Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Our lead program, AlloNK®, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers. AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed’s innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.