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

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

Join to apply for the Senior Manager Biostatistics R&D (m/f/x) role at Daiichi Sankyo Europe GmbH.

Company Overview

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on protecting people from cardiovascular disease and advancing oncology through breakthrough science. Our European headquarters are in Munich, Germany, with affiliates in 15 European countries and Canada.

Role Purpose

We are seeking a Senior Biostatistician to support oncology development within an international clinical development team. Reporting to the Director of 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.

Skills and Qualifications

• 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.

Application Documents

• Application letter & CV
• Further qualification documents

What We Offer

• Excellent benefits
• Work‑life balance
• Growth and development opportunities
• Health and wellbeing support

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Research, Analyst, and Information Technology

Industries

Pharmaceutical Manufacturing

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