Director Biostatistics
Job Id: 284963
Location: Billerica, Massachusetts, United States
Job Type: Full-time
About the Role
Join EMD Serono as a Director of Biostatistics and play a pivotal role in drug development. As part of a cross-functional team, you will be responsible for designing evidence generation strategies to support decision-making and contribute to successful drug development programs. You will take the lead in the statistical aspects of clinical studies, data analysis, and interpretation of results, supporting marketing authorization and reimbursement efforts. Your expertise will guide the development of human research study designs, lead statistical matters, and manage a team of statisticians.
In this role, you will be responsible for ensuring the quality and timeliness of statistical analyses, communicating findings to both technical and non-technical audiences, and ensuring that human research study results are interpreted objectively. You will represent Biostatistics externally, collaborate with Health Authorities and external partnerships, and help shape departmental standards and process improvements.
Key Responsibilities
Lead and contribute to the integrated evidence plan for drug development programs, ensuring value creation for patients and supporting marketing authorization and reimbursement.
Provide statistical leadership in clinical studies and drug development, managing the design, analysis, and interpretation of results.
Take accountability for statistical matters, leading matrix teams of statisticians.
Ensure high-quality and timely performance of statistical analyses and communicate results to both technical and non-technical stakeholders.
Ensure objective interpretation of study results to support informed decision-making.
Represent Biostatistics externally, interacting with Health Authorities and supporting external partnerships.
Drive the development of departmental standards and process improvements.
Qualifications
Education: Ph.D. or MS in Statistics, Biostatistics, or a related discipline.
Experience:
At least 8 years of experience in the pharmaceutical/biotechnology industry, with a focus on clinical development.
Comprehensive expertise in drug development, with knowledge of interdependencies with other functions.
Experience in oncology is preferred.
Skills:
Excellent team player with strong communication and influencing skills.
Ability to work in a diverse, global environment.
In-depth knowledge of relevant guidance documents (ICH, FDA, EMA, etc.).
Strong leadership competencies: results-driven, innovative, collaborative, and future-oriented.
Compensation & Benefits
Pay range: $143,700 - $215,500 (varies based on location, experience, and other factors).
Benefits:
Medical, vision, and dental insurance.
Life and disability insurance.
401(k) matching program.
Paid time off and holidays.
Potential for short-term or long-term incentive compensation (including cash bonuses).
What We Offer
At EMD Serono, we embrace diversity and foster an inclusive culture that drives innovation. We believe that diverse perspectives fuel excellence, and we are committed to providing opportunities for professional development and growth at your own pace.
Apply now and join our team to make an impact on the future of healthcare!
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