Senior Biostatistician & Clinical Trials Lead

Cytel; Cheyenne (WY); Remote; USD 180,000 - 240,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead one or more Phase I-IV clinical studies for a major pharmaceutical client. You will provide statistical leadership, design studies, develop SAPs, and oversee analyses while collaborating with cross-functional teams in a fast-paced environment.

The role requires a PhD preferred, 8–10 years of biostatistics, and expertise in R, SAS, CDISC, and ISS/ISE submissions.

Qualifications

• Master's degree in Statistics, Biostatistics, or a related discipline. PhD strongly preferred.
• 8-10 years of biostatistics experience supporting clinical trials within the pharmaceutical or biotechnology industry. CRO experience strongly preferred.
• 3-5 years of Study Lead experience working with cross-functional development teams.
• Extensive experience in study design, sample size determination, protocol development, SAP development, efficacy analyses, and preparation of clinical study reports, including integrated summaries for regulatory submissions (ISS/ISE).
• Strong knowledge and practical application of advanced statistical methods, including mixed models, longitudinal analyses, and simulation methodologies.
• Demonstrated experience performing exploratory statistical analyses to support clinical development and decision-making.
• Strong proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling.
• Solid SAS programming skills, including QC of critical outputs, efficacy and safety tables, and close collaboration with Statistical Programmers.
• Strong knowledge of ICH guidelines and regulatory expectations.
• Solid understanding and implementation of CDISC standards for regulatory submissions.
• Experience generating ADaM specifications and performing programmatic review of analysis datasets.
• Regulatory submission experience (ISS/ISE) strongly desired.
• Excellent communication skills with the ability to explain statistical methodology and its implications to both technical and non-technical audiences.
• Strong collaborative mindset with a commitment to delivering high-quality work under tight timelines.
• Ability to thrive in a dynamic environment, manage ambiguity, and adapt to changing priorities.

Responsibilities

• Participating in the development of study protocols, including study design discussions and sample size calculations.
• Participating in exploratory data analyses to evaluate emerging study trends, support scientific decision-making, and generate insights throughout the course of development.
• Applying advanced statistical methodologies, including mixed models and other complex modeling techniques, to support efficacy and longitudinal analyses.
• Designing and executing simulation studies to evaluate study designs, operating characteristics, and statistical methodologies.
• Leading and contributing to efficacy analyses and interpretation of primary and secondary endpoints.
• Reviewing CRFs and data review guidelines; developing Statistical Analysis Plans (SAPs), including analysis dataset and TLF specifications.
• Performing statistical analyses and interpreting statistical results.
• Leading study activities when called upon and providing strategic statistical guidance to cross-functional teams.
• Utilizing strong communication skills to present statistical methodology, assumptions, and the implications of decisions in clear, non-technical language.
• Serving as a collaborative team player with a willingness to go the extra distance to meet project goals and timelines.
• Demonstrating adaptability and flexibility as project priorities evolve.

Skills

Statistical methods

Communication

Cross-functional leadership

Adaptability

Education

Master's degree in Statistics/Biostatistics

PhD preferred

Tools

R

SAS

CDISC

ADaM

Job description

Cytel is seeking an experienced Principal Biostatistician to lead one or more Phase I-IV clinical studies for a major pharmaceutical client. You will provide statistical leadership, design studies, develop SAPs, and oversee analyses while collaborating with cross-functional teams in a fast-paced environment.

The role requires a PhD preferred, 8–10 years of biostatistics, and expertise in R, SAS, CDISC, and ISS/ISE submissions.