Director, Biostatistics

Our Immunotherapy client based in Lexington, MA is looking to add a Director, Biostatistics to their team!  Reporting to the Biometrics Head, the candidate will be working in a cross-function team to provide the statistical expertise to multiple Research and Development programs. The successful candidate will be responsible for leading, developing, and implementing statistical solutions to assure timely completions of Biometrics deliverables. 

Responsibilities:

  • Provide leadership, guidance, and strategic input as the lead statistician on one or more projects
  • Accountable for statistical aspects of clinical development plans, studies and submission activities
  • Participate in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents 
  • Oversee definition and implementation of study/project level database (including derived database), analysis and reporting standards. Coordinate with Data Management and Programming to target high quality databases and specifications at project level
  • Plan and direct study/project level analysis and reporting activities (eg, tables, listings, graphs) including work of other statisticians and programmers
  • Conduct statistical analyses for clinical trials and provide expertise on SAS procedures
  • Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables
  • Consider and evaluate alternative analysis methodology and data presentation techniques
  • Collaborate with clinical research and development team to support publications, regulatory submissions, and other related activities including statistical innovation research

Requirements:

  • PhD in statistics/biostatistics with minimum of 8+ year of experience in pharma/biotech
  • Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, summarization of data presentation and interpretation practices
  • Strong statistical research ability for statistical methodology
  • Experience with IND, NDAs, MAAs and other regulatory submissions a plus
  • Ability to work effectively in a cross-functional environment
  • Strong statistical programming skills using SAS, R and other relevant software
  • Experience with clinical research preferred
  • Good communication and interpersonal skills
  • Strong project management and communication skills
  • Excellent knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents
  • Excellent knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials