Biostatistics Director

Location
94520, Concord
Posted
Dec 07, 2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

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.

Primary Responsibilities:

  1. Lead statistical activities in support of product development and product registrations.
  2. Collaborate with cross-functional teams and thought leaders in study planning (e.g., study design, sample size estimation, endpoint selection).
  3. Responsible for statistical integrity and accuracy of data analysis.
  4. Interact with FDA or other regulatory agencies in statistical aspects of study design, data analysis, and choice of statistical methodologies.
  5. Author or review statistics section in protocols, statistical analysis plans (including definitions of derived variables and mock tables/listings), study reports, and DSMB charters.
  6. Provide statistical advice and support to clinical researchers.
  7. Provide quality oversight to CROs in activities related to statistical analysis and data management.
  8. Work with department head to develop, implement, and maintain department standards and practices.

Qualifications/Requirements/Skills:

  1. Ph.D. in Biostatistics or Statistics with a minimum of 8 years experience in the pharmaceutical/biotechnology industry supporting clinical studies.
  2. 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.
  1. Time management skills (timelines, schedules, task prioritization).

Team player being able to adapt to changing priorities.