Executive Director, Biostatistics
DUTIES – RESPONSIBILITIES:
The Executive Director of Biostatistics will provide senior leadership, vision, management and direction on clinical trial design, inference, analyses and decision-making within Oncology drug programs and clinical development plan strategy. The incumbent will direct and execute the statistical aspects of protocols, analyses and regulatory submissions for clinical development programs based on optimal clinical trial designs, quantitative decision-making and analytical assessment. The incumbent will be assigned to serve as the Lead Statistician on given clinical trial(s) with responsibilities including study design, data analysis and interpretation, statistical analysis plan development and vendor management. The incumbent may mentor and manage other team members while guiding internal and external project teams on the data collection methodology for statistical analyses. The Executive Director, Biostatistics may write or oversee the writing of Standard Operating Procedures (SOPs). Excellent ccommunication skills are required to effectively correspond with Sr. management, regulatory agencies, internal/external teams and in written material (e.g. briefing documents).
The major competencies required in this position are as follows:
• Strong knowledge of statistical, regulatory and clinical development landscapes.
• Leadership in successfully advancing drug product(s) to market
• Leadership in implementing innovative designs and analysis methods
• Problem solving, conflict resolution and cross-functional integration
• Effective communication in a team setting utilizing strong interpersonal skills and technical expertise
• In depth understanding of CDISC/CDASH standards including SDTM structure to successfully lead submission tasks and vendor oversight.
• Writing Statistical Analysis Plans and Manuals; reviewing plans and charters; contributing statistical input to CRFs; drafting TLFs; preparing sample size estimations; writing/reviewing statistical sections of NDAs, INDs etc, as appropriate.
• Managing in-house Statistical Programming and/or other Statistical resources
• Providing statistical input to data management process
• Reviewing and/or developing publications, abstracts and presentations
• Ability to integrate cross-functionally with Drug Safety, Regulatory, Clinical Operations, Medical Affairs and Data Management
Education: Ph.D. required in Biostatistics, Statistics, Mathematics
Experience: Candidates being considered for this position must possess a minimum of twelve years experience in pharmaceutical drug development
Knowledge and experience in the following areas:
• Full working knowledge and practical experience supporting clinical teams to design protocol endpoints and to write statistical methods sections of protocols including sample size calculations.
• Experience writing statistical analysis plans, data analysis, and generating tables, listings and graphs for clinical study reports.
• Expertise and knowledge in Oncology and data interpretation
• Experience in CRO management
• Experience with statistical input of CRF design and programming specifications.
• Prior experience with managing direct reports a plus.
• NDA/MAA experience and direct dealings with USA/European regulators
• Experience with EDC systems
• An acumen for teaching
• SAS analysis programming skills essential (SAS/Stat, graph, macro)
• Experience with other statistical software and graphics packages a plus
• Excellent communication skills and technical writing experience