The Principal Biostatistician serves as lead statistician for one or more clinical studies. He or she works closely with the clinical team on the statistical design of the studies, and the analysis and data presentations for the studies.
Reporting Relationship: Associate Director Biostatistics or higher
- Serves as lead statistician for one or more clinical studies, leading the statistical design of study, authorizing statistician sections in protocol and Statistical Analysis Plan (SAP).
- Reviews Case Report Forms to ensure data is collected appropriately to achieve the analysis defined in the protocol.
- Creating data presentation plan and tables, listings and figures (TFL) shells.
- Provides guidance to statistical programmers on SDTM/ADaM and TLFs specifications development.
- Performs programming validation for key derived datasets as required and oversee Quality Control efforts for data presentations and TFLs have been followed.
- Closely works with study team to ensure the statistical integrity of study conduct.
- Plans, manages and oversees CRO statistical activities.
- Other duties as assigned.
- PhD or MS in statistics or biostatistics or related fields.
- Minimum of 3 years (for PhD) and 5 years (for MS) related experience or equivalent combination of education and experience.
- Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Advanced proficiency in BASE SAS, or other statistical software is advantageous, but not required.
- Effective verbal and writing skills.
Job Location: Cambridge, MA
Please send resumes to email@example.com