Senior Manager /Associate Director, Biostatistics

Position Responsibilities

• Provide statistical leadership for one or multiple clinical studies from Phase 1 through Phase 3.
• Provide accurate and detailed statistical support for clinical trial design, including but not limited to, phase 1 healthy volunteer trials, early dose-finding clinical studies, mid- and late-stage efficacy trials, safety trials, and clinical and pre-clinical pharmacokinetic studies.
• Conduct statistical analysis/modeling across different stages of development to meet project objectives and guide further clinical development, including but not limited to, comparing different study designs and implementing pre-specified analysis plan or ad-hoc analyses.
• Develop or review Statistical Analysis Plans, including mock displays for TFLs, programming specifications for analysis datasets.
• Ensure high-quality statistical deliverables, including statistical outputs, and lead the data interpretation.
• Represent biostatistics in study team and clinical development team meetings, lead the statistical discussion.
• Contribute to the development of randomization schedules and supply management algorithms.
• Author statistical sections and contribute to the development of regulatory documents including clinical protocols, study reports, Investigator Brochures, INDs, briefing documents/package, integrated summaries, etc.
• Support regulatory interactions with agencies.
• Provide oversight of statistical activities when outsourced to external vendors
• Contribute to publications, scientific presentations

Candidate Requirements

• Doctorate degree in statistics, biostatistics or related field. A minimal of 2 years of relevant drug development experience in biotech or pharmaceutical companies for Senior Manager, or a minimum of 4 years for Associate Director
• Ability to work independently, manage multiple programs/studies, remain highly organized and outcome-oriented, demonstrate self-motivation, and adapt in a fast-paced, growing environment
• Strong analytical thinking and strategic problem-solving skills.
• Sound decision-making skills and the ability to navigate complex business and scientific challenges
• Excellent communication skills in writing and in interactions with colleagues, including the ability to clearly describe advanced/complex statistical concepts and interpret results.
• Ability to influence cross-functional teams in a matrixed, global organization
• Thorough and up-to-date working knowledge of statistical methodologies and clinical trial designs, with the ability to propose and implement novel approaches to accelerate clinical development and address challenges in rare disease settings.
• Thorough and up-to-date working knowledge of FDA and ICH regulations and industry standards includes but not limited to applicable to the design and analysis of clinical trials.
• Experience NDA/BLA/EMEA filings experience is strongly preferred
• Proficient in SAS programming.
• Proficient in R programming is strongly preferred
• Experience managing CROs and external vendors is preferred
• Ability to accommodate up to 20% travel or as business needs dictate