Senior Manager, Biostatistics

Responsibilities

• Provide statistical leadership for one or more clinical development programs, ensuring consistency and quality of statistical deliverables.
• Serve as a key contributor to protocol development and study design.
• Prepare statistical analysis plans.
• Lead the 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.
• Manage statistical responsibilities of clinical studies from program development through CSR creation and publication, collaborating with other biostatisticians and statistical programmers.
• Review and approve statistical deliverables produced internally or by CRO partners, ensuring compliance with regulatory standards and company expectations.
• 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, and development of briefing book materials.

Qualifications

• PhD. in biostatistics or statistics with at least 4 years, or Master’s degree with at least 6 years of experience within biotech/pharma or related field.
• Experience leading statistical aspects of the design, analysis, and reporting of clinical trials.
• Strong understanding of clinical trial design principles, including adaptive designs.
• Ability to balance scientific rigor with operational and business considerations in a fast-paced development environment.
• Knowledge and extensive hands-on experience with CDISC methodologies and industry data standards.
• Demonstrated ability to manage multiple priorities and timelines while delivering high-quality outputs.
• Excellent ability to communicate complex statistical concepts in non-technical language.
• 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 strongly desired.
• 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 is a plus.