Principal Biostatistician: Drive Clinical Development

Cytel; Saint Paul (MN); On-site; USD 150,000 - 230,000; Full time

Job summary

Cytel is seeking a Principal Biostatistician to lead one or more Phase I–IV trials within our sponsor environment. You will provide statistical development support, design studies, develop SAPs, and guide cross-functional teams through analysis plans and regulatory submissions.

You will apply advanced methods (mixed models, simulations) and modern analytics to create actionable insights, collaborating closely with clients and Cytel experts to advance development timelines.

Qualifications

• Master's degree in Statistics, Biostatistics, or a related discipline. PhD strongly preferred.
• 8-10 years of biostatistics experience supporting clinical trials in the pharmaceutical/biotech industry; CRO experience preferred.
• 3-5 years of Study Lead experience with cross-functional development teams.
• Extensive experience in study design, sample size determination, protocol development, SAP development, and ISS/ISE preparation.
• Strong knowledge and practical application of advanced statistical methods (mixed models, longitudinal analyses, simulations).
• Proven ability to perform exploratory analyses to support development and decision-making.
• Strong proficiency in R for analyses, simulations, data visualization and modeling.
• Solid SAS programming skills and QC of outputs for efficacy and safety tables.
• Strong knowledge of ICH guidelines and regulatory expectations; CDISC standards for regulatory submissions.
• Experience generating ADaM specifications and programmatic review of analysis datasets.
• Regulatory submission experience (ISS/ISE) is highly desirable.
• Excellent communication skills to explain methods to technical and non-technical audiences.
• Collaborative mindset with ability to deliver high-quality work under tight timelines.

Responsibilities

• Participating in study protocol development, design discussions, and sample size calculations.
• Leading exploratory data analyses to evaluate trends and support scientific decisions.
• Applying advanced statistical methods including mixed models to support efficacy and longitudinal analyses.
• Designing and executing simulation studies to evaluate designs and methodologies.
• Leading efficacy analyses and interpreting primary and secondary endpoints.
• Reviewing CRFs and data review guidelines; developing SAPs with Datasets and TLF specs.
• Performing statistical analyses and interpreting results.
• Leading study activities and providing strategic statistical guidance across teams.
• Communicating statistical methodology clearly to diverse stakeholders.
• Ensuring adaptability as project priorities evolve.

Skills

R programming

SAS programming

CDISC standards

ISS/ISE experience

Study lead

Cross-functional leadership

Statistical methods

Mixed models

Education

Master's degree in Statistics/Biostatistics

PhD preferred

Job description

Cytel is seeking a Principal Biostatistician to lead one or more Phase I–IV trials within our sponsor environment. You will provide statistical development support, design studies, develop SAPs, and guide cross-functional teams through analysis plans and regulatory submissions.

You will apply advanced methods (mixed models, simulations) and modern analytics to create actionable insights, collaborating closely with clients and Cytel experts to advance development timelines.