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.

Director, Biostatistics

Key skills