Clinical affairs manager Jobs in Puchheim

Associate Director Biostatistics (Oncology)

Mainz, Germany; London, United Kingdom; Munich, Germany; Paris, France; Randstad, Netherlands | full time | Job ID : 8824

Your main responsibilities are :

• Represent Statistics in all assigned cross-functional clinical study teams and other projects and holds him / herself accountable for all statistical aspects
• Work as part of a collaborative, cross-functional team with members from other disciplines
• Provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
• Perform and / or verify sample size calculations
• Lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results
• Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
• Oversee outsourced statistical CRO activities and deliverables ensuring highest quality and in a timely manner
• Support and participate in the development of departmental strategies
• Provide guidance to Statistical Programmers on SDTM / ADaM and TLFs specifications development and programming
• Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met

What you have to offer :

Your Benefits : BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note : The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.