Director/Associate Director Biostatistics

Permanent

Penfield Search Partners

Our client is the US division of one of the largest companies in China. Their pipeline is highly diversified and includes products in Oncology, Immunology, Pain, and Metabolics. They are looking for a Biostatistician to come in at the Director or Associate Director level to lead all aspects of Biostatistics activities on global clinical projects. As part of a multi-disciplinary team, the Director/AD will ensure statistically sound design, appropriate analysis strategy and provide statistical support for regulatory submissions. The incumbent will provide statistical input into other disciplines activities and participate in interdepartmental processes; will also provide technical solutions and advise staff and clients on optimal statistical processes.

  • Represent Statistics to provide both key input in the planning of clinical trials (e.g. study design, sample size, randomization strategy) and advanced input into statistical sections and overall consistency of clinical study protocols
  • Develop and/or review statistical analysis plans (SAP)
  • Determine appropriate analyses strategies for clinical endpoints based on input from the protocol and the client and provide statistical programming procedures as needed
  • Prepare or review mock shells for planned tables, listings and graphs to ensure consistency with the SAP
  • Collaborate with the programming team to prepare specifications for SDTM/ADaM datasets to be used for interim and final analyses
  • Perform high level reviews of datasets produced by the programming team for accuracy and provide statistical input into design/review of format of CRFs and helps ensure data quality
  • Perform and/or oversee the preparation, execution, reporting and documentation of statistical analyses
  • Be responsible for the statistical considerations in regulatory submissions, including but not limited to, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE); provide oversight for the conduct of integrated analyses by internal programming teams or external vendors
  • Prepare and review statistical methods and results sections for the clinical study report (CSR) with in-house medical writers and provide statistical support for study publications
  • Stay current with the latest regulatory guidelines and good industry practices
  • Ensure appropriate communication and documentation for Biostatistics aspects of the assigned projects; represent the department during audits

Please have:

  • PhD in Statistics and 4+ years industry experience or MS 6+
  • Experience in the design of clinical trials (e.g. sample size and power analysis, randomization schedule)
  • Ability to conduct Monte Carlo simulation for complex/adaptive designs is highly preferred
  • Proficiency in SAS and/or R
  • Excellent problem solving and analytical skills and good analytical skills
  • Working knowledge of SDTM / ADaM standards (or considerable experience working with analysis or derived datasets)
  • Experience with regulatory submissions in the US and EU
  • Good knowledge of ICH guidelines and regulatory guidelines

 

Tagged as: Director/Associate Director, Biostatistics