Job Description
Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop first-in-class therapeutics in the field of cancer immunotherapy. Our therapeutic pipeline consists of immuno-oncology programs against novel drug targets we discovered computationally, including T cell immune checkpoints and additional early-stage immune-oncology programs focused largely on myeloid targets. As we advance our pipeline, we are looking for a highly motivated Director of Statistical Programming to lead multiple clinical programs.
The Director of Statistical Programming is a member of the clinical team who will be responsible for managing, leading, and overseeing statistical programming planning and operational activities to meet corporate objectives, timelines, and budgets. The Director is responsible for providing statistical programming support for multiple clinical projects and multiple clinical studies through own effort and/or manage CROs and provides guidance and direction to subordinates to achieve tasks in accordance with department and Company goals. This person works closely with cross-functional teams including clinical development, biostatistics, safety/pharmacovigilance, clinical biomarker, and data management colleagues on various clinical projects. The Director is responsible to liaise with data management and other functions to enhance the integrity of data. This position reports to the Chief Medical Officer.
Job Description
- MS in Biostatistics, Statistics, or related field required
- 15 years’ experience of statistical programming within pharmaceutical clinical development
- Experience in managing technical professionals or CRO in regulated environment
- Regulatory knowledge and filing experience
- Proficient in SAS software and programming concepts and techniques in the pharmaceutical industry
- Experience of leading early and late-phase clinical studies including programming and validation of SDTM and ADaM datasets, and TFLs
- Proficient in industry standards (CDSIC, SDTM and ADaM), medical terminology, and clinical trial methodologies
- Possesses project management skills within the statistical programming function
- Strong leadership, teamwork, and communication skills
- Regulatory (FDA and EMA) submission experience
- Willing to travel if required
