Who Are You?
As a Lead Principal Biostatistician, you will play a pivotal role while working intimately with one of our major Pharma clients, focusing on transforming clinical trials for drug development. This role offers an excellent opportunity for you to apply your extensive expertise in late-phase trials and regulatory submissions specifically for Oncology studies.
Join a Dynamic Team:
Fully embedded within a renowned global pharmaceutical company, you'll have the support of Cytel while being at the forefront of client innovation. As a vital member of our client's team, you will enjoy autonomy and ownership in your contributions during this exciting phase of their program.
Position Overview:
Our Lead Principal Biostatisticians provide indispensable statistical leadership and development support for our client’s clinical trials. You will be responsible for influencing clinical development plans, creating detailed protocols, and potentially overseeing project deliverables managed by external vendors.
In this role, your responsibilities will include:
• Offering statistical leadership and expertise in clinical development plans and protocols, representing Cytel on Product Development Teams for our sponsors.

• Leading statistical teams to align objectives and ensuring timely delivery of high-quality statistical outputs that meet project specifications.

• Providing essential input into study protocols, Case Report Forms, and data management plans, while also drafting statistical analysis plans, developing analysis dataset specifications, and conducting statistical analyses.

• Reviewing and contributing to study reports and regulatory submission dossiers, leading electronic submissions of clinical data to regulatory bodies, and engaging in discussions with regulatory agencies.

• In a lead capacity, managing biostatisticians and statistical programmers in terms of statistical strategies, deliverables, and procedural processes.

• Collaborating on sourcing strategy development for various projects.

• Building strong partnerships and effective communication with cross-functional teams and Biostatistics management.

At Cytel, we are dedicated to the success and growth of our employees through comprehensive training and support. To excel in this role, you will need:
• A Master's degree in statistics or a related field; a Ph.D. is highly desirable.

• A minimum of 6 years of experience in supporting clinical trials within the Pharmaceutical or Biotechnology sectors.

• At least 3 years of recent involvement in late-phase drug development, including drafting Statistical Analysis Plans (SAPs), calculating sample sizes, and reviewing TLFs.

• Strong experience in managing biostatisticians and statistical programmers, specifically in lead roles.

• Preferred experience in Oncology studies.

• Comprehensive knowledge of the pharmaceutical industry and its regulatory landscape is advantageous.

• Proficiency in SAS and/or R programming for quality control of critical outputs, including Efficacy/Safety tables, and effective collaboration with programming teams.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. We welcome applicants for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.