Senior Biostatistician & Study Lead - Clinical Trials

Cytel; Bismarck (ND); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel Inc. is seeking an experienced Principal Biostatistician to lead Phase I-IV clinical studies within our client ecosystem. You will provide statistical leadership, design studies, and advise cross-functional teams on SAS and R-based analyses.

You will develop SAPs, perform advanced modeling, simulate designs, and communicate complex results to non-technical stakeholders while meeting regulatory expectations (ISS/ISE). Strong collaboration and adaptability are essential.

Qualifications

• Master's degree in Statistics, Biostatistics, or related discipline.
• 8–10 years of biostatistics experience in clinical trials.
• 3–5 years of Study Lead experience with cross-functional teams.
• Strong knowledge of advanced statistical methods and modeling.
• Proficient in R for analyses, simulations, and visualization.
• Solid SAS programming skills and outputs QC.
• Knowledge of ICH guidelines and regulatory expectations.
• CDISC standards implementation for regulatory submissions.
• Experience generating ADaM specs and ISS/ISE submissions.
• Excellent communication for technical and non-technical audiences.

Responsibilities

• Participating in study design discussions and sample size calculations.
• Engaging in exploratory data analyses to support decision-making.
• Applying mixed models and complex modeling for efficacy analyses.
• Designing and executing simulation studies to evaluate designs.
• Leading efficacy analyses and interpretation of endpoints.
• Reviewing CRFs and developing SAPs and TLF specifications.
• Performing statistical analyses and interpreting results.
• Leading study activities and guiding cross-functional teams.
• Communicating statistical methodology clearly to stakeholders.
• Collaborating with team members and adapting to priority changes.
• Demonstrating flexibility to meet project goals and timelines.

Skills

R

SAS

Mixed models

Education

Master’s degree in Statistics/Biostatistics

PhD preferred

Tools

R

SAS

Job description

Cytel Inc. is seeking an experienced Principal Biostatistician to lead Phase I-IV clinical studies within our client ecosystem. You will provide statistical leadership, design studies, and advise cross-functional teams on SAS and R-based analyses.

You will develop SAPs, perform advanced modeling, simulate designs, and communicate complex results to non-technical stakeholders while meeting regulatory expectations (ISS/ISE). Strong collaboration and adaptability are essential.