We are seeking highly qualified candidates to fill the position of:

Senior Manager Biostatistics R&D (m/f/x)

Purpose of the Role:

We are seeking a Senior Biostatistician to support oncology development within an international clinical development team. Reporting to the Director Biostatistics, you will lead complex study design and statistical analysis efforts, collaborating closely with cross-functional teams and external partners such as contract research organizations (CROs).

Roles and Responsibilities:

• Lead statistical activities for complex oncology studies, including study design, protocol development, case report form review, statistical analysis plan development, data analysis, and clinical study report contributions

• Serve as the primary statistical contact for assigned studies, providing expert guidance to study teams and ensuring high-quality data in collaboration with data managers

• Provide input into drug development plans to ensure scientifically sound study designs that meet regulatory requirements and target product profiles

• Oversee CROs and vendors by reviewing proposals and budgets, setting expectations, and ensuring timely and accurate delivery of statistical analyses

• Contribute to global Health Authority submissions and may participate in meetings or teleconferences with regulatory agencies such as FDA and EMA

• Support and occasionally lead initiatives to improve drug development efficiency and harmonization, contributing to cost savings and shortened timelines

Personal Skills and Professional Experience: 

• Extensive experience in biostatistics within oncology clinical trials, with strong knowledge of regulatory requirements including FDA, EMA, and ICH guidelines
• Proven expertise in statistical methods for survival analysis and proficiency with statistical software such as SAS and R
• Experience managing CROs and leading cross-functional project teams in a pharmaceutical environment
• Master’s degree in Statistics or Biostatistics required; PhD preferred
• 8+ years of relevant industry experience with a Master’s degree, or 5+ years with a PhD
• Excellent communication skills and ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving skills, able to work independently under some supervision while managing complex study challenges

This position is eligible for a referral amount of € 2.000.
*The Bonus will be paid out after the referral has successfully completed the first 6 months.

Application documents:

• Application letter & CV

• Further qualification documents