Director Biostatistician R

2 weeks ago


Billerica, United States EMD Serono Full time

Work Your Magic with us Start your next chapter and join EMD Serono.

Ready to explore, break barriers, and discover more? We know you've got big plans '“ so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**:As Director of Biostatistics, you will play a key role in the success of drug development, as part of a team that encourages career growth and development. As a statistical leader working in a cross-functional team, you will be responsible to develop an appropriate strategy for evidence generation to create value in a drug development program and to support evidence-based decision-making, maximizing probability of success. As Director of Biostatistics, you may independently lead very complex studies or one or more drug projects in study design, data analysis and interpretation of results, authoring regulatory responses and other documents with mínimal supervision.

Key responsibilities:

- Provide statistical leadership in the creation of the integrated evidence plan for a drug development program to create value for patients and support marketing authorization and reimbursement.
- Provide statistical leadership in the development of human research study designs and take accountability for statistical matters, providing matrix leadership of other statisticians.
- Ensure that statistical analyses are effectively performed and conducted in high quality and in a timely manner and communicated to both technical and non-technical audiences.
- Ensure the objective interpretation of human research study results to support informed decision-making
- Represent Biostatistics externally, e.g., interaction with Health Authorities, external partnerships, wider statistical community, industry working groups.
- Provide statistical leadership in the evaluation of in-licensing opportunities, focusing on product value and probability of success.
- Provide statistical leadership in indication or disease area strategy.
- Support the development and implementation of departmental standards and process improvements. Contribute to continuous learning and development activities and to the mentoring of junior colleagues.

**Who you are:
**Minimum Requirements**

Ph.D. or MS in Statistics, Biostatistics or related discipline

**Preferred Requirements**
- At least 10 years of experience in the Pharmaceutical/Biotechnology industry in clinical development
- Excellent team player (both within the project and within the function), strong communication and influencing skills, fluent in English
- Experience working in a diverse, global working environment.
- Comprehensive expertise in drug development, including knowledge of interfaces and interdependencies with other functions.
- Excellent knowledge of relevant guidance documents (from ICH, FDA, EMA, etc.), using them pro-actively to impact the performance or find alternative solutions Strong leadership competencies: purposeful, results-driven, innovative, collaborative, future-oriented

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress


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