Director, Biostatistics - Late Phase

The Opportunity:

Playing a critical role as a lead statistician for clinical program(s) and studies in clinical late-stage development and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function, this position is to provide statistical leadership and support for clinical development strategy and clinical studies through product life cycle. 

• Provide statistical support and strategic input to clinical development plans, proof of concept criteria, and team’s preparation for company governance reviews.

• Represent Biostatistics function on cross-function teams and serve as a lead statistician for oncology studies.

• Collaborate with various functions on study design and planning, protocol development, statistical analysis plan and analysis specifications.

• Provide statistical support for study protocol development, analysis plan and specification.

• Plan and prepare independent data monitoring committee (DMC), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews.

• Collaborate with data management and clinical operations over the course of clinical studies to provide statistical input to study conducts and database development as well as data collection and cleaning activities.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Provide statistical input and leadership to the development of global health authority documents, regulatory interaction and response to health authority submissions.

• Provide statistical support for clinical publications, assist in data interpretation to ensure consistency and accuracy in data presentation.

• Drive and lead department initiatives, best practices, and guidelines.

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in the biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.

• Hands-on experience in design and analysis of late-stage oncology trials is a must.

• Ability to work independently and within a team.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Active participation in NDA/BLA filing through label negotiations is desirable. 

  #LI-Hybrid  #LI-SH1