Who Are You?
As a Senior Principal Biostatistician, you will be a key player for one of our major Pharma clients, leading and supporting groundbreaking clinical trials aimed at drug development in the Oncology field. This role offers an incredible opportunity to apply your expertise in late-phase trials and regulatory submissions.
Sponsor-dedicated:
You will work closely with one of our esteemed pharmaceutical clients, fully integrated into their team while having the robust support of Cytel behind you. This position places you at the forefront of innovative patient treatment strategies, where you can thrive with autonomy and a sense of ownership. Join us at this pivotal time for a new program.
Position Overview:
Our Senior Principal Biostatisticians not only provide crucial statistical and strategic guidance for clinical trials but also influence clinical development plans, concept sheets, and protocols. Additionally, you may oversee contributions from other vendors to ensure project success.
Your responsibilities will include:
• Deliver statistical leadership and expertise for clinical development plans, ensuring representation of Cytel and the statistical team within the clients' Product Development Teams.

• Lead statistical teams throughout clinical development projects, ensuring alignment with objectives and timelines, while coordinating all statistical facets across trials.

• Provide essential input on study protocols, Case Report Forms, and data management plans. You will write statistical analysis plans, review dataset specifications, and conduct statistical analyses.

• Review and contribute to study reports and clinical/statistical sections of regulatory submission dossiers, lead the electronic submission of clinical data to authorities, and participate in regulatory meetings.

• When in the Lead Biostatistician role, manage biostatisticians and statistical programmers in terms of statistical strategy and deliverables.

• Assist in developing sourcing strategies for projects to optimize resource allocation.

• Foster strong collaboration and communication with cross-functional teams and sponsor Biostatistics management.

At Cytel, we are committed to your success, offering ongoing training, development, and support. To thrive in this role, you should possess:
• A Master's degree in statistics or a related area; a Ph.D. is highly desirable.

• 6+ years of experience in supporting clinical trials within the Pharmaceutical or Biotechnology industries.

• A minimum of 3 years' recent work in late-phase (II & III) drug development, including drafting SAPs, calculating sample sizes, and reviewing TLFs.

• Experience managing biostatisticians and statistical programmers for project deliverables and strategies.

• Preferred experience in Oncology studies.

• Strong knowledge of the pharmaceutical industry and its regulatory landscape is a plus.

• Proficiency in SAS and/or R programming for quality control of key outputs, efficacy/safety tables, and effective collaboration with programmers.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. We welcome applicants from all walks of life, regardless of race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.