Senior Statistician

TL;DR

Senior Statistician (Biostatistics): Leading biostatistics activities for clinical trials with an accent on protocol development, statistical analysis plans, and regulatory compliance. Focus on performing complex statistical analyses, validating SAS programs, and consulting on experimental design to assess drug safety and efficacy.

Location: Munich, Germany

Company

A dynamic, global contract research organization founded in 1995, dedicated to advancing medical science and bringing new medicines to patients.

What you will do

• Lead all biostatistics activities for clinical trials as the responsible project statistician.
• Develop and review statistical sections of protocols, including sample size calculations and analysis plans.
• Document analysis database structures and define SAS program requirements.
• Perform statistical analysis, validate SAS programs, and review statistical deliverables.
• Consult on experimental design and statistical methods for safety and efficacy assessments.
• Train junior statisticians and SAS programmers while participating in bid defense and investigator meetings.

Requirements

• MSc in Statistics or equivalent degree.
• Expert knowledge of statistical principles and standards in clinical research.
• Advanced proficiency in SAS programming and CDISC ADaM standards.
• Strong understanding of regulatory guidelines including FDA, EMA, and ICH.
• Ability to interpret complex research requirements and determine statistical strategies.
• English proficiency required for all professional communication.

Culture & Benefits

• Work on the frontline of medical science with a global team of over 2,700 professionals.
• Collaborative environment focused on quality and patient impact.
• Opportunities for professional development and training within a stable, long-standing organization.