Associate Director - Permanent - Cambridge, MA
Proclinical is seeking an Associate Director of Statistical Programming with expertise in CDISC standards to join a dynamic team in the Oncology therapeutic area. This position also involves establishing and maintaining internal data and programming standards to drive consistency, efficiency, and compliance across clinical development programs.
Primary Responsibilities:
The successful candidate will lead statistical programming activities, oversee vendor deliverables, and ensure the development of high-quality, regulatory-compliant outputs.
Skills & Requirements:
- Degree in Statistics, Computer Science, Mathematics, Public Health, or a related quantitative field.
- Strong understanding of ICH Guidelines, regulatory requirements, and CDISC standards.
- Expertise in SAS programming and statistical analysis implementation.
- Experience in Oncology therapeutic area preferred.
- Familiarity with regulatory filings (e.g., NDA, BLA) and expectations of agencies like FDA and EMA.
- Excellent communication, organizational, and negotiation skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Demonstrated agility, flexibility, and problem-solving skills in a biotech setting.
- SAS LSAF experience is a plus.
The Associate Director's responsibilities will be:
- Lead statistical programming activities at the study level, ensuring high-quality deliverables and adherence to timelines.
- Serve as the CDISC subject matter expert, collaborating with functional management to design, develop, and implement data standards.
- Develop, validate, and maintain analysis datasets, tables, listings, and figures (TLFs) in accordance with regulatory guidelines.
- Collaborate cross-functionally and with CROs to design and develop study documents, including SDTM and ADaM packages.
- Review, quality control, and approve analysis data transfers (e.g., SDTM, ADaM) and other statistical deliverables.
- Provide feedback on statistical analysis plans (SAPs) and contribute to programming strategies for execution.
- Perform hands-on programming to support complex statistical analyses and demonstrate expertise in 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.
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