Welcome to Professional Resources, Inc.
Submit Your Resume View All Jobs

Title:Assistant Director, Biostatistics
Salary:Open
Experience:4+
Location:NJ - Jersey City

Description:
The Assistant Director of Biostatistics will work closely with Statistical Programmers in test runs, identify data quality issues for key efficacy and safety variables, and work closely with Statistical Programmers in the final statistical analyses, including results interpretation.

Responsibilities:
  • Review protocol and prepare statistical sections, including sample size calculation
  • Review CRF, database design, and edit check specs
  • Prepare detailed statistical analysis plan, including derived dataset specifications and table/listing shells
  • Review final study report and prepare statistical methods sections
  • Participate in drug development activities
  • Provide support to new drug submission/ approval/ marketing
  • Provide leadership for Biostatistics, Programming, and Data Management study team
  • Perform other ad-hoc statistical activities as needed
  • Mentoring senior/senior principal statisticians

Requirements:
  • Ph.D. in Statistics or Biostatistics
  • At least 4 years of pharmaceutical statistics experience
  • Good knowledge of SAS computer package
  • Good communication skills (verbal and written)
  • Good project management skills
  • Good knowledge of clinical trial methodologies and regulatory guidelines
  • Good interpersonal skills

Submit Your Resume View All Jobs