Director, Biostatistics

at  TSP A Syneos Health Company

DESIRED EXPERIENCE/EDUCATION AND PERSONAL ATTRIBUTES:

• Ph.D. or M.S., Biostatistics or equivalent with at least 5 years of pharmaceutical, biotechnology industry experience
• Must have experience in Oncology
• Profound understanding of advanced clinical trial design and statistical analysis methodologies
• Good understanding of the big picture of an overall development program
• Capable of thinking strategically
• Excellent communication and interpersonal skills
• Ability to lead project teams, as well as work in a cross-functional team
• Strong ability to quickly capture key information from medical journal articles
• Understand regulatory requirements and good clinical practice guidelines
• Ability to multitask and prioritize work
• Good statistical programming skills using SAS and other statistical software
• Good leadership and consultation skills
  Remote opportunity

• Play an active role in designing efficient clinical trials
• Collaborate with clinical trial team to support study conduct, analysis and reporting
• Serve as an influential statistical consultant to medical and development team
• Independently conduct clinical trial simulations
• Independently perform clinical, biomarker, and PK/PD data analyses
• QC and interpret clinical trial results
• Write statistical analysis plans, statistical sections of protocols, and reports
• Review relevant medical literature
• Help develop protocols, case report forms, and clinical study reports
• Develop TLF shells and review programming specs
• Engaged in clinical data review for data quality and integrity
• Act as an integral member of project team, collaborate effectively with other team members, and attend project team meetings
• Perform statistical programming for advanced statistical methodologies and help statistical programmers QC their programs
• Conduct quality review of statistical analyses; conduct ad hoc analyses if needed.
• Keep updated with regulatory requirements
• Support interactions with regulatory authorities
• Provided oversight to biometrics vendors