Director/Sr. Director, Statistical Programming

About Artiva:

Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization.  

AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis,  Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren’s  Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers.

Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California.

For more information, visit www.artivabio.com.

Job Summary: 
​​​​As the Director/Sr. Director, Statistical Programming, you will lead the Statistical Programming function for our clinical development programs at Artiva, contributing to the vision, direction, and strategy of the statistical programming function.  You’ll build strong collaboration with clinical development and study teams to identify and meet their needs for statistical programming support. 

Duties/Responsibilities: 

Lead and oversee statistical programming activities across clinical programs. 

Establish and maintain program standards, processes, and best practices aligned with regulatory expectations. 

Use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listing tables and figures and create all files necessary to support an electronic submission in the eCTD format 

Ensure programming deliverables meet timelines, quality standards, and submission requirements. 

Contribute to the preparation of regulatory submissions 

Must possess extensive experience and proven skills in the use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles 

Support responses to regulatory questions and inspections related to programming and data standards. 

Ensuring that the filing of study documentation is maintained to the standard according to processes and acceptable for audit 

Manage adherence to all company policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards 

Evaluate, develop, revise, implement, and ensure compliance to functional guidelines policies and SOPs 

Collaborate across all functional areas to ensure programming needs are met with specific regards to study data specifications, applications, and computing environment support 

Collaborate closely with Biostatistics Clinical Data Management, Pharmacovigilance, Clinical Operations and other functions within Artiva to address their needs for programming support 

Collaborate closely with Preferred Vendor management in terms of governance recruiting needs contract development and signature and any other partnership requirement that may arise 

Requirements: 

PhD/PharmD and 8 years of experience OR Master’s and 10 years of experience OR Bachelor’s and 12 years of experience 

10+ years statistical programming experience in biotech/pharmaceutical industry 

Extensive experience of leading both early- and late-phase clinical studies, including programming and validation of SDTM and ADaM data sets, tables, figures, and listings 

Expert-level SAS programmer with experience in delivering complex programming assignments, macros and analyses 

Experience in management of CROs with respect to statistical programming 

Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization

In addition to a great culture, we offer:

· 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.

If all this speaks to you, come join us on our journey!

Base Salary: $210,000 - $270,000. Exact compensation may vary based on skills and experience.