Senior Manager, Biostatistics, Real World Evidence

Location
Cambridge, MA, US
Posted
Sep 05, 2019
Ref
944
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time

 Join bluebird bio’s enthusiastic and collaborative Clinical Development Operations (CDO) team by contributing to the overall success of our novel gene therapy programs. Reporting to a Director of Biostatistics, the successful candidate will be responsible for leading statistical efforts for real world evidence (RWE) projects and/or clinical studies. 

 Position Overview:

The Senior Manager, Biostatistics role will be responsible for overseeing statistical activities for RWE and/or clinical studies, participating study designs and protocol development, ensuring compliance with SOPs to produce quality and timely deliverables. This individual will participate in departmental and cross functional technology development and process improvement initiatives.

About the Role:

  • Serve as a lead statistician and manage statistical efforts for RWE and/or clinical studies
  • Contribute to protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
  • Author statistical analysis plans for studies, and author/edit shells for tables, figures and listings
  • Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
  • Work with statistical programmers or CROs to generate tables, figures and listings
  • Support ongoing safety data review for development studies and for post marketing activities
  • Perform ad hoc and exploratory statistical analyses as needed
  • Contribute to study reports, including authoring the statistical sections and interpretation of the study results
  • Support regulatory submissions, including performing analyses for value base health technology assessment
  • Support the preparation of publications, including manuscripts, posters and oral presentations
  • Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs

 About You:

  • PhD in statistics or a related field with at least 3 years of relevant post marketing study or observational study experience or clinical study experience, or MS in statistics or equivalent with at least 6 years of relevant post marketing study or observational study experience or clinical study experience
  • Knowledge of statistical methods for RWE and/or clinical trials
  • Knowledge of FDA, EMA and ICH regulations and guidelines
  • Proficient in statistical programming (SAS is required and R is a plus)
  • Experience in analyses using real world data including electronic health records to support post marketing projects is a plus
  • Good communication skills and ability to work with cross-functional study teams
  • Good organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Good analytical and problem solving skills
  • Positive, outgoing and collaborative attitude
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself