Senior Director, Biostatistics

Key Responsibilities

• Lead the biometrics team including statistician, data manager, and statistical programmer at a program level
• Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies
• Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies
• Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings
• Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data
• Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance & Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines
• CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines
• Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities
• Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses

Qualifications

• PhD Degree in Biostatistics, Statistics, or a related field with at least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry
• Strong knowledge of statistical methodologies and their application in clinical trials and health research
• Working knowledge of Bayesian methodology is preferred
• Experience with regulatory submissions and interactions with regulatory agencies
• Proficiency in statistical software (e.g., SAS, R) and data management systems
• Experience with CDSIC including SDTM, ADaM, CDASH
• Successful track record of working independently in a matrixed organization and providing solutions to emerging problems
• Excellent communication and interpersonal skills, along with organizational skills
• Ability to work collaboratively in a multidisciplinary team environment