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

Daiichi Sankyo; Reims; À distance; EUR 90 000 - 120 000; Plein temps

Résumé du poste

A global biopharmaceutical company seeks a Senior Manager in Biostatistics R&D to lead statistical activities for oncology development. This role involves collaboration with cross-functional teams and managing complex study designs and analyses. Candidates should have extensive oncology trial experience and strong knowledge of regulatory requirements. This position offers a referral bonus and emphasizes a culture of inclusion and diversity.

Prestations

Referral bonus of €2,000

Continuous learning opportunities

Inclusive company culture

Qualifications

• 8+ years of experience in oncology clinical trials with a Master’s degree.
• 5+ years of experience with a PhD.
• Extensive knowledge of FDA, EMA, and ICH guidelines.

Responsabilités

• Lead statistical activities for complex oncology studies.
• Serve as primary statistical contact for assigned studies.
• Provide expert guidance to study teams.

Connaissances

Biostatistics

Survival analysis

Statistical software proficiency (SAS, R)

Project management

Communication skills

Analytical skills

Formation

Master’s degree in Statistics or Biostatistics

PhD in a related field

Outils

SAS

R

Description du poste

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

Date: 8 Sept 2025

Location: All Europe, Europe, 81379

Passion for Innovation. Compassion for Patients.

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 two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.

In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

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.

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.