Manager, Biostatistics

Responsibilities

• Provide statistical leadership for one or more clinical development programs, ensuring consistency and quality of statistical deliverables.
• Manage statistical responsibilities of clinical studies from program development through CSR creation and publication, collaborating with other statisticians and statistical programmers.
• Serve as the primary statistical point of contact for assigned programs and studies.
• Serve as a key contributor to protocol development and study design.
• Perform sample size calculations. Develop and/or review statistical analysis plans.
• Contribute to the design and analysis of clinical trial and real-world data to support evidence generation for company products from randomized controlled trials and observational studies.
• Establish effective collaboration with cross-functional team members, including clinical development, medical affairs, clinical operations, data management, and regulatory affairs.
• Review and approve statistical deliverables produced internally or by CRO partners, ensuring high quality deliverables and compliance with regulatory standards and company expectations.
• Manage biostatistics CRO partners, ensuring quality and adherence to SOPs.
• Partner with clinical and regulatory teams to proactively identify risks and mitigation strategies related to statistical design and analysis.
• Support interactions with regulatory authorities on statistical topics, including participation in meetings, responses to information requests, development of preparation materials and briefing book materials for meetings and communications with regulatory authorities.

Qualifications

• Master’s Degree in statistics, biostatistics from accredited college or university.
• Minimum 2 years of experience within the biotech/pharmaceuticals industry or a related field.
• Experience in statistical responsibilities for design, analysis, and reporting of randomized controlled trials.
• Strong understanding of clinical trial design principles, including adaptive designs.
• Ability to effectively communicate complex statistical analyses and concepts to non-statisticians in non-technical language.
• Demonstrated ability to manage multiple priorities and timelines while delivering high-quality outputs.
• Working knowledge of regulatory guidelines and expectations in pharmaceutical development; experience supporting regulatory interactions is a plus.
• Programming experience in SAS is required; experience in R is a plus.
• Familiarity with real-world evidence and observational research methodologies (e.g., causal inference) is a plus.
• Prior experience supporting clinical development programs in acute or chronic pain indications is a plus.
• Understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry.