Senior Biostatistician

A global biopharmaceutical company is looking for a Senior Biostatistician to join their growing biometrics practice. It’s an exciting opportunity to be part of their Real-World Evidence practice supporting their Immuno-Oncology portfolio. For this position, you will be reporting directly into the Director of Biostatistics.

Work Summary

As part of your day-to-day tasks, you will be assisting the clinical team on the company's drug development program on Immuno-Oncology. Your role will be to deliver your expertise on all statistical topics involving sample size calculation and discuss with external vendors on all statistical methodologies.

Responsibilities of a Senior Biostatistician:

• Manage all the statistical activities (SOP, SAP, Study Protocol etc..) and act as the sole point of contact for all statistical enquiries from internal to external stakeholders.
• Take part in application development for small programs and new drug applications.
• Create and developing statistical platforms such as Statistical analysis plans and create clinical study report and handling of Bayesian statistics.
• Programming validation of R and quality control of all statistical deliverables.
• Develop program requirements of R and specifications as well as reviewing all the outputs in relation to statistics such as table listings and figures.

Requirements of a Senior Biostatistician:

• Master in Biostatistics or relevant field of study.
• Extensive experience working within a Pharmaceutical, Biotechnology or CRO Setting.
• Strong experience working with R Programming and CDISC standards (Reviewing ADaM and SDTM datasets).
• Previous experience working with Clinical Trials is required.
• Proficient expertise of statistical methodologies such as Bayesian Statistics and principles and knowledgeable of regulatory guidelines such as the EMA or the FDA.

If you are interested in the Senior Biostatistician position, apply online today, or contact Trevor Logendrant at +44 1293300863 or +49 697 104 0313 for more information.