Role 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.
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.
Qualifications
- 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