Biostatistician – varying levels (3)

Permanent

Penfield Search Partners

Our client is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Their in-depth knowledge of non-opioid pain management, coupled with their passion for advancing patient care, drives a commitment to providing solutions that address unmet medical needs and improve clinical results in this crucial area.

The Senior Manager/Associate Director, Biostatistics is responsible for managing and directing Statistical Programmers on a project, writing statistical sections for protocols, authoring statistical analysis plans, reviewing and QCing deliverables from the Biostatistics department and mentorship of others in the department. The incumbent will also be responsible for overseeing quality control of statistical deliverables from CRO partners.

  • Oversee statistical support to multiple project teams
  • Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols
  • Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project
  • Oversee execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries
  • Review and approve key results memos and statistical conclusions
  • Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package
  • Ensure statistical representation at regulatory or other external meetings
  • Prepare data packages relevant for submission and making key decisions
  • Produce statistical deliverables consistently compliant, in timing and quality, with SOPs and departmental standards

 

Please have:

 

  • MS/PhD in Statistics
  • 5+ years of experience in Biostatistics or related area or PhD in statistics, biostatistics or related area and 3 or more years of experience in biostatistics or related area
  • Experience in analyzing data from: Efficacy, Parallel. Cross-over, Pharmacokinetic and Dose-response studies
  • Demonstrated understanding of drug/device development
  • Demonstrated knowledge of regulatory process and guidelines
  • Programming experience in SAS is required; experience in R is a plus
  • Proven understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry
  • Excellent presentation skills
  • Demonstrated broad knowledge and superior understanding of advanced statistical concepts and techniques
  • Proven ability to innovatively apply technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
  • Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
  • Demonstrated in-depth understanding of the regulatory drug submission / approval process regionally and globally
  • Proven ability to effectively represent Biostatistics and Programming in multidisciplinary or cross-functional meetings

Tagged as: Biostatistician - varying levels (3)