Associate Director, Statistical Programming

Reporting to the Senior Director (Head) of Statistical Programming, the Director, Statistical Programming, is responsible for overseeing all statistical programming deliverables in adherence to ICH/GCP/CDISC guidance. The individual works closely with the Senior Director, Statistical Programming to create and implement statistical programming policies and procedures, provide oversight on analysis of clinical trials, and support internal analysis needs. Responsibilities: Responsible for the statistical programming activities for CSR, publications, presentations, various reports for health authority submissions, clinical data review, and ad-hoc analysis either internally or through CRO partners. Work with the biostatistician to build and maintain secure statistical computing and programming infrastructure. Interact with members of project teams, biostatistician, and data management personnel to establish project timelines and perform statistical analyses. Manage and provide oversight of Statistical Programming FTEs, contractors, and CROs to ensure high-quality statistical analysis deliverables (datasets, TLFs, etc.) within timeline and budget. Author or Review SDTM and ADaM specifications to ensure compliance to CDISC standards Review key clinical study or program documents. Develop SAS code, manage macro library and templates for efficiently preparing, processing, analyzing clinical data and validating analysis results. Author and/or review statistical analysis related SOPs. Additional duties and responsibilities as required. Qualifications: