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.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.