FULL-TIME
Posted Jul 4, 2026
Job Description
Who Are You? If you are a seasoned Principal Biostatistician eager to make an impact in the realm of Oncology drug development, we want to hear from you! Join us as a vital member of our team, working directly with one of our leading pharmaceutical clients. This role offers the exceptional opportunity to apply your expertise in late-phase clinical trials and regulatory submissions, driving innovative patient treatments.
Position Overview: As a Principal Biostatistician, your contribution will be at the forefront of our client's clinical development initiatives. Your responsibilities will include:
• Providing statistical leadership and expertise into clinical development plans, study concepts, and protocols.
• Leading statistical teams on clinical projects, ensuring timely delivery and alignment with project objectives.
• Contributing to the design and oversight of study protocols, case report forms, and data management plans.
• Writing statistical analysis plans, reviewing analysis datasets, and performing comprehensive statistical analyses.
• Reviewing and supporting study reports and regulatory submission documentation.
• Engaging with regulatory authorities and leading electronic submissions of clinical data.
• Managing and mentoring biostatisticians and statistical programmers when in a lead role.
• Fostering collaboration with cross-functional teams and Biostatistics management.
Why Join Us? At Cytel, we are dedicated to your success through comprehensive training, development opportunities, and unwavering support. To excel in this role, you should possess:
• A Master's degree in statistics or related discipline (Ph.D. preferred).
• 6+ years of experience in clinical trials within the pharmaceutical or biotechnology industry.
• At least 3 recent years of involvement in late-phase (II & III) drug development, including drafting statistical analysis plans (SAPs) and sample size calculations.
• Experience in Oncology studies is highly desirable.
• Strong knowledge of the pharmaceutical industry and regulatory environment.
• Proficient SAS and/or R programming skills, essential for quality control of critical outputs.
Cytel Inc. values diversity and is an Equal Employment Opportunity employer. We welcome applicants from all backgrounds and walks of life.
Position Overview: As a Principal Biostatistician, your contribution will be at the forefront of our client's clinical development initiatives. Your responsibilities will include:
• Providing statistical leadership and expertise into clinical development plans, study concepts, and protocols.
• Leading statistical teams on clinical projects, ensuring timely delivery and alignment with project objectives.
• Contributing to the design and oversight of study protocols, case report forms, and data management plans.
• Writing statistical analysis plans, reviewing analysis datasets, and performing comprehensive statistical analyses.
• Reviewing and supporting study reports and regulatory submission documentation.
• Engaging with regulatory authorities and leading electronic submissions of clinical data.
• Managing and mentoring biostatisticians and statistical programmers when in a lead role.
• Fostering collaboration with cross-functional teams and Biostatistics management.
Why Join Us? At Cytel, we are dedicated to your success through comprehensive training, development opportunities, and unwavering support. To excel in this role, you should possess:
• A Master's degree in statistics or related discipline (Ph.D. preferred).
• 6+ years of experience in clinical trials within the pharmaceutical or biotechnology industry.
• At least 3 recent years of involvement in late-phase (II & III) drug development, including drafting statistical analysis plans (SAPs) and sample size calculations.
• Experience in Oncology studies is highly desirable.
• Strong knowledge of the pharmaceutical industry and regulatory environment.
• Proficient SAS and/or R programming skills, essential for quality control of critical outputs.
Cytel Inc. values diversity and is an Equal Employment Opportunity employer. We welcome applicants from all backgrounds and walks of life.
Additional Details
- City
- Lincoln
- State
- Nebraska
- Country
- US
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