Instagram
youtube
Facebook

Director Biostatistics (Billerica Ma)

8+ years
$143,700 - $215,500
10 April 28, 2025
Job Description
Job Type: Full Time Education: PhD/MS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director, Biostatistics
Job Id: 284963
Location: Billerica, Massachusetts, United States
Job Type: Full-time

About the Role
Join EMD Serono as a Director in Biostatistics, where you'll play a key role in drug development and support evidence-based decision-making. As a statistical leader within a cross-functional team, you'll oversee complex clinical studies and contribute to the integrated evidence plan for drug development programs. Your work will help create value for patients, support marketing authorization, and influence reimbursement decisions. You will be responsible for statistical leadership, developing human research study designs, and managing high-quality statistical analyses.

Key Responsibilities

  • Evidence Generation: Lead the development of evidence generation strategies for drug development programs and ensure effective statistical analysis to support decision-making.

  • Clinical Study Leadership: Independently lead complex clinical studies and oncology drug development projects, managing study design, data analysis, and interpretation of results.

  • Statistical Leadership: Provide statistical leadership in human research study designs and matrix leadership of other statisticians, ensuring high-quality, timely analyses.

  • Regulatory and External Engagement: Represent Biostatistics in interactions with Health Authorities and external partnerships. Support regulatory responses and contribute to the development of departmental standards and process improvements.

  • Collaborative Leadership: Work collaboratively with diverse, global teams and demonstrate strong communication and influencing skills in a cross-functional setting.

Who You Are

  • Education: Ph.D. or MS in Statistics, Biostatistics, or related discipline.

  • Experience: At least 8 years of experience in the Pharmaceutical/Biotechnology industry in clinical development.

  • Leadership Skills: Proven leadership competencies, including innovation, collaboration, and a results-driven approach.

  • Oncology Expertise: Experience in oncology is preferred.

  • Global Experience: Ability to work in a diverse, global environment and apply knowledge of relevant guidance documents (e.g., ICH, FDA, EMA).

  • Communication: Strong communication and influencing skills, fluent in English.

Location
Billerica, MA

Pay Range
$143,700 - $215,500 (Dependent on factors including location, skills, experience, and career level.)

Benefits

  • Medical, vision, and dental insurance

  • Life insurance

  • Disability insurance

  • 401(k) matching program

  • Paid time off and paid holidays

  • Short-term or long-term incentive compensation, including cash bonuses

What We Offer
We are dedicated to creating a culture of diversity, inclusion, and belonging. Our commitment to these values drives excellence and innovation, allowing our employees to thrive in a dynamic and supportive environment.

Apply now and become part of our diverse team!