Senior/Principal Biostatistician, FSP (Client-dedicated) at Thermo Fisher Scientific

Senior/Principal Biostatistician, FSP (Client-dedicated) - Home based, EMEA

• We are looking for Senior Biostatisticians who implement diverse statistical tasks supporting the clinical development programs. The tasks mainly focus on handling the statistical activities performed by the biometrics CRO and on guarantying by means of thorough review outstanding statistical quality. You will be involved throughout the full clinical trial process, from study design and protocol writing, over defining the statistical analyses (SAP) to reviewing all study outputs and the CSR.

Key Accountabilities/Responsibilities:

The senior 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. The trials can be 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.
• Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI).
• Contributes to press releases and scientific papers.

Desired Skills and Experience:

• 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.
• Master’s degree in statistics or biostatistics required.
• Minimum of 6-8 years of biostatistical experience desired.
• Experience in handling CROs and vendors is a plus
• Biotech experience is a plus
• Auto-immune and/or oncology clinical study background is a plus