Principal Biostatistician, FSP (Client-dedicated) - Home based, EMEA at Thermo Fisher Scientific

Key Accountabilities/Responsibilities:

• The Principal Biostatistician is responsible for all clinical aspects for the assigned global clinical studies from preparation until archiving.

The study responsibilities include:

• Serves as the responsible biostatistician on Phase I to III clinical trials, ranging from relatively simple or complex.
• Contributes to clinical study synopses and protocols.
• Develops statistical analysis plans and/or performs senior review of statistical analysis plans.
• Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
• Provides relevant input in the development and review of CRFs.
• Performs lead review and sets up internal QC of TFLs.
• Performs critical review of derived datasets specifications and derived datasets (ADaM).
• Contributes to clinical study reports.
• Reviews simple to complex randomization specifications and dummy randomization schemes.
• Participates in bid defense meetings.
• Oversight of project financials.
• Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI).
• Contributes to press releases and scientific papers.

Skills and Experience:

• Master’s degree in statistics or biostatistics required.
• Minimum of 6-8 years of biostatistical experience, plus lead statistician experience.
• Experience in handling CROs and vendors.
• Experience with Data Monitoring Committees (DMC's)
• Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
• Proficient with other statistical software such as R, EAST, Winbugs is a plus.
• Detailed knowledge of and experience with CDISC standards is desired.
• Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
• Displays excellent communication skills with proven leadership ability.
• Knowledge of ICH-GCP and other applicable legislation to successfully implement the clinical study.