Manager, Biostatistics

  •  

Philadelphia, PA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 36 days ago

  by    Jenny Ann Nunez

This job is no longer available.

Title: Manager, Biostatistics

Company: CRO

Location: Remote

Type: Permanent Role

Notes: No Corp to Corp

Job Description:

  • Independently develops SAS programs to generate listings, tables and figures as outlined by a statistical analysis plan and to generate randomization codes
  • Performs QC of TLFs, CDISC and other analysis data sets
  • Prepares specifications for CDISC and other analysis data sets
  • Independently develops statistical analysis plans
  • Acts as Lead Biostatistician to interact with the study team and the Sponsor
  • Supports Business Development by preparing for and attending bid defense meetings, preparing capabilities presentations, and assisting with budget and proposal development.
  • Acts as an independent Biostatistician on DSMBs and DMCs
  • Acts as Project Manager for one Biostatistics stand-alone project, and completes consultancy work as needed
  • Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop the team structure

Requirements:

  • Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field
  • 10 years of experience in clinical trials design and analysis using SAS
  • 2 to 5 years of experience as supervisor/manager
  • Prior experience using computerized information systems preferred.
  • Ability to read, write, and speak fluent English; fluent in host country language.
  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
  • Works with internal and external customers/vendors to meet project specific goals.
  • Identifies, monitors, documents, and tracks out-of-scope activities.