Sr Biostatistician I/II (FSP)

We have partnered with a leading global CRO who are recruiting for Sr Biostatistician I/II to join their Biostatistics department working fully remotely in the UK or mainland Europe. Due to a period of sustained growth, our client is looking to expand their Biostats department in the UK/Europe. As a Sr Biostatistician I/II, you will join their innovative Biostatistics department working dedicated to one of their Biotech clients in EMEA.

The Sr Biostatistician will work directly with the client as part of their team. Will execute diverse statistical tasks supporting the clinical development programs within the client setting. The tasks mainly focus on managing the statistical activities performed by the biostatistics CRO and on guaranteeing by means of thorough review outstanding statistical quality. 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.

The Role:

• 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.

Qualifications:

• Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
• Fluent with other statistical software such as R, EAST, Winbugs is a plus.
• Thorough 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 demonstrated leadership ability.
• Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study.
• Master’s degree in statistics or biostatistics required.
• Minimum of 4+ years of biostatistical experience desired.
• Experience in managing CROs and vendors is a plus.
• Biotech experience is a plus.
• Auto-immune and/or oncology clinical study background is a plus.

The Culture:

Truly collaborative and winning culture. Thousands of employees in locations worldwide. Local feel atmosphere. Access to resources globally. Collaborative environment where colleagues are eager to share expertise and have fun together.

What do you get in return?

• Exposure to industry-leading statistical, programming and clinical pharmacology.
• An award-winning learning and development programme, ensuring you reach your potential.
• A competitive salary, an extensive benefits package based around health and well-being.
• Flexible working culture - where a work-life balance is valued!
• Very generous sign on bonus!

What to do next?

If this opportunity is of interest, please apply now with your CV as they are looking to arrange interviews in the near future.