Manager-AD Statistical Programming - Oncology

We have a current opportunity for a Manager-AD Statistical Programming - Oncology on a permanent basis. The position will be based in California, but offers remote option. For further information about this position please apply.

Job Title: Manager / Associate Director, Statistical Programming - Oncology

Position Summary:

We are seeking a highly motivated and experienced Manager or Associate Director of Statistical Programming to join our growing Biometrics team. This role will serve as a lead programmer on pivotal oncology studies, overseeing programming deliverables, ensuring compliance with regulatory standards, and collaborating cross-functionally to support clinical development strategies.

Key Responsibilities:

• Serve as the lead statistical programmer on complex oncology clinical trials (Phase I-III), ensuring high-quality and timely deliverables.
• Oversee and manage internal and external programming resources, including CROs, to ensure alignment with project timelines and quality standards.
• Develop, validate, and maintain SDTM, ADaM, and TLFs in accordance with CDISC standards and regulatory requirements.
• Act as the subject matter expert (SME) for SDTM, ensuring consistency, accuracy, and compliance across studies.
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory Affairs to support data analysis and submission activities.
• Contribute to the development and maintenance of programming standards, SOPs, and best practices.
• Participate in regulatory submission activities including eCTD package preparation and response to agency queries.
• Mentor and provide technical guidance to junior programmers and contractors.

Qualifications:

• Bachelor's or Master's degree in Statistics, Computer Science, Life Sciences, or a related field.
• 8+ years of experience in statistical programming within the pharmaceutical or biotechnology industry, with 5+ years in oncology.
• Proven experience as a lead programmer on oncology studies, including regulatory submissions (e.g., NDA, BLA).
• Must have deep expertise in SDTM development and validation, including mapping raw data to SDTM domains and resolving complex data issues.
• Strong proficiency in SAS programming/Analytics; knowledge of R or Python is a plus.
• Solid understanding of CDISC standards (SDTM, ADaM) and regulatory guidance (e.g., FDA, EMA).
• Excellent project management, communication, and leadership skills.
• Experience working in a global, cross-functional team environment.