Biotech/Pharmaceutical

Sr. Manager Biostatistics

Permanent

Penfield Search Partners

Contact: John Mailey – 203.955.1312 – jmailey@penfieldsearch.com

Job Description: The Senior Manager, Biostatistics will be functioning as a statistical lead on company clinical development projects.  This position will work collaboratively with clinicians, data managers, biostatisticians, and statistical programmers in the planning, conduct, and analysis of clinical studies in all phases.

Essential Functions:

  • Provide timely and scientifically sound statistical expertise to clinical development projects and develop/execute statistical strategy, design, and analyses for clinical trials
  • Work with biostatistics compound/therapeutic area lead, peer management, and employees to develop, implement, and maintain department standards and practices
  • Develop/write statistical analysis plans and provide data interpretation.
  • Develop statistical programs as necessary to perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming
  • Collaborate with members of project teams to establish project timelines and to develop and implement protocols
  • Help design data capture methods and select appropriate study endpoints for clinical programs
  • Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results
  • Provide guidelines and standards to CROs to ensure quality of deliverables
  • Respond to statistical questions from regulatory agencies

Minimum Requirements:

  • PhD or Master’s Degree in Statistics, Mathematics, or related fields
  • A minimum of 5 years of experience in pharmaceutical or biotechnology industry is required
  • Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials
  • Good knowledge of drug development regulations pertinent to statistical analysis
  • Experience in contributing to NDAs/BLAs submission
  • Proficient SAS programming skills, solid understanding of CDISC models and standards
  • Excellent writing and communication skills, and demonstrated interpersonal skills

Tagged as: Sr. Manager Biostatistics