As a statistical lead, the candidate will work collaboratively with cross-functional teams in planning, conduct, analysis, and reporting of pre-clinical and clinical studies to support U.S. and international registration applications. The candidate will also participate in planning and writing of abstracts, manuscripts, and presentations.
- Lead statistical activities in support of product development and product registrations.
- Collaborate with cross-functional teams and thought leaders in study planning (e.g., study design, sample size estimation, endpoint selection).
- Responsible for statistical integrity and accuracy of data analysis.
- Interact with FDA or other regulatory agencies in statistical aspects of study design, data analysis, and choice of statistical methodologies.
- Author or review statistics section in protocols, statistical analysis plans (including definitions of derived variables and mock tables/listings), study reports, and DSMB charters.
- Provide statistical advice and support to clinical researchers.
- Provide quality oversight to CROs in activities related to statistical analysis and data management.
- Work with department head to develop, implement, and maintain department standards and practices.
- Ph.D. in Biostatistics or Statistics with a minimum of 8 years experience in the pharmaceutical/biotechnology industry supporting clinical studies.
- Strong attention to detail and accuracy.
- Ability to integrate statistical and biomedical concepts.
- Proficiency with at least one major statistical software packages (e.g., SAS, R).
- Experience in CDISC data standards (e.g., SDTM, ADaM).
- Excellent communication skills with ability to interact across all levels and influence upwardly.
- Time management skills (timelines, schedules, task prioritization).
Team player being able to adapt to changing priorities.