Director/Sr. Director, Statistical Programming

Artiva Biotherapeutics•San Diego, CA

8d•$210,000 - $270,000

About The Position

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.

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

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

Benefits

A beautiful facility
An entrepreneurial, highly collaborative, and innovative environment
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.