Director, Statistical Programming

Overview of Role:

The Director of Statistical Programming oversees managing statistical programming projects and creating strategic plans related to clinical trials and medical affairs publications. They lead the team in developing, maintaining, validating and running SAS programs that analyze and report clinical trial data, following statistical analysis plans, ICH guidelines and regulatory requirements. They are responsible for the structure of the statistical programming function and representing the function in cross-functional activities, particularly in regard to data collection, analysis, and integration of clinical trial data and real-world evidence.

Role and Responsibilities:

• Provides technical and/or operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions.
• Works closely with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs.
• Works closely with Data Management on cross-functional data review and the development and validation of CDISC SDTM specifications and datasets and define packages, may also support Drug Safety to support safety data review and reporting needs, and/or Clinical Pharmacology to support their dataset creation and analytic needs.
• Manages internal and vendor statistical programming support; Maintains strong collaboration and governance with preferred vendors.
• Writes SAS programs that produce or validate tables, listings, figures, and analysis datasets, in support of clinical studies or complex integrated analyses for submission.
• Performs, plans, and coordinates project work to ensure timely, quality delivery across multiple projects, or across a drug program.
• Writes specifications to describe programming needs, including development and maintenance of complex / ADaM specifications and reviewer guides.
• May lead the creation and validation of global macros or systems that streamline repetitive operations to increase programming efficiency.
• Provides input into, or leads general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations).
• Leads efforts to develop programming processes consistent with industry best practices.
• Reviews and provides expert input to DMP, eCRF specs, and other clinical data management documents; Reviews and provides expert input to statistical analysis plans and other related documents.
• Partners with or oversees CROs or Programming vendors to perform any of the above tasks.

Experience, Education and Specialized Knowledge and Skills:

• PhD with 8+ years of experience or MS with 11+ years of experience in statistics or biostatistics or related disciplines with clinical trials, pharmaceutical/biotech industry, or healthcare experience
• Experience in supporting oncology phase II/III clinical studies
• Experience in organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA)
• In-depth knowledge of CDISC standards
• Technical expertise and knowledge of experimental design and analyses using SAS, R, or EAST, and etc.
• Excellent written and verbal communication skills
• Good working knowledge of ICH, FDA and GCP regulations and guidelines
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
• Strong computer and database skills
• Attention to detail, accuracy and confidentiality
• Clear and concise oral and written communication skills
• Excellent organizational skills
• Critical thinking, problem solving, ability to work independently.
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
• Communicate effectively and articulate complex ideas in an easily understandable way
• Prioritize conflicting demands.
• Work in a fast-paced, demanding and collaborative environment