Director, Biostatistics

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.

Experience with trial design software (e.g., EAST).

Understanding data standards, including SDTM and ADaM.

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.