Director, Biostatistics

• →Provide/validate sample size/power calculation and author statistical section of the protocol.
• →Responsible for the development of study SAP and table/figure/listing shells including overseeing CRO’s work.
• →Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Regulatory and other functions to meet project deliverables and timelines.
• →Provide statistical and strategic inputs in documents prepared for regulatory interactions.
• →Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
• →Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results.
• →Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations.

• PhD in biostatistics or related discipline with 7+ years, or Master's Degree with 10+ years of experience in the pharmaceutical or biotech industry.
• Demonstrated ability and experience in the design, analysis and reporting of clinical trials.
• Knowledge of design considerations. Familiarity with CNS endpoints and associated analysis methodologies highly desirable.
• Extensive knowledge of FDA, EMA and ICH regulations and industry standards applicable to the design and analysis of clinical trials and regulatory submissions.
• Proficient in statistical programming (SAS and R). Experience with trial design software (e.g., EAST).
• Ability to concurrently lead statistical efforts for multiple projects.
• Understanding data standards, including SDTM and ADaM.
• Adept at overseeing statistical services provided by CRO's.
• Excellent verbal and written communication skills; Ability to communicate statistical information to non-scientists, willingness to educate internal team.

Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA.