Director - Permanent - Cambridge, MA
Proclinical is seeking a Director of Statistical Programming to lead statistical programming activities within the Oncology therapeutic area. This position requires a blend of technical expertise, leadership, and project management skills to support clinical development and regulatory submissions.
Primary Responsibilities:
The successful candidate will oversee in-house programming efforts and manage vendor collaborations to ensure high-quality, regulatory-compliant outputs. You will work closely with cross-functional teams to optimize processes, drive operational excellence, and implement innovative solutions.
Skills & Requirements:
- Degree in Statistics, Computer Science, Mathematics, Public Health, or a related quantitative field.
- Strong experience in statistical programming within the pharmaceutical or clinical research industry, particularly in clinical trials.
- Comprehensive knowledge of ICH Guidelines, regulatory requirements, and CDISC standards.
- Expertise in SAS programming and familiarity with statistical analysis implementation.
- Preferred experience in Oncology therapeutic areas and regulatory filings (e.g., NDA, BLA, ISS, ISE).
- Familiarity with regulatory agency expectations (e.g., FDA, EMA).
- Excellent communication, organizational, and negotiation skills.
- Ability to work independently and collaboratively in a dynamic, fast-paced environment.
- Demonstrated agility, flexibility, and problem-solving capabilities in a biotech setting.
- Experience with SAS LSAF is a plus.
The Director's responsibilities will be:
- Serve as the lead programmer for study or project-level statistical programming activities, ensuring timely and high-quality deliverables.
- Develop, validate, and maintain analysis datasets, CDISC standards, and tables, listings, and figures (TLFs) in compliance with regulatory guidelines.
- Collaborate with cross-functional teams and CROs to design and develop study documents, including SDTM and ADaM packages and analysis outputs.
- Review, quality control, and approve analysis data transfers (e.g., SDTM, ADaM) and other statistical deliverables.
- Provide feedback on statistical analysis plans (SAPs) and define programming strategies to execute them effectively.
- Offer expertise in statistical programming for regulatory submissions, including electronic submission standards (e.g., eCTD).
- Perform hands-on programming to support complex statistical analyses and demonstrate a deep understanding of clinical trial data.
- Build and maintain software-agnostic solutions, such as macros, to automate repetitive tasks.
- Propose innovative solutions to better understand and utilize clinical trial data.
- Stay updated on industry trends, best practices, and emerging technologies in statistical programming and data analysis.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy
