Principal Biostatistician: Lead Clinical Trials & Analytics

Cytel; Carson City (NV); On-site; USD 140,000 - 210,000; Full time

Job summary

Cytel seeks an experienced Principal Biostatistician to lead Phase I-IV clinical studies across the region. You will develop integrated analysis plans, mentor teams, and partner with clients to advance development possibilities with rigorous statistical methodology and practical decision-making.

This role requires strong expertise in study design, mixed models, simulation, and regulatory submissions (ISS/ISE).

Qualifications

• Master's degree in Statistics, Biostatistics, or related discipline; PhD strongly preferred.
• 8-10 years of biostatistics experience in pharmaceutical/biotechnology 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, efficacy analyses, ISS/ISE.
• Strong knowledge of advanced statistical methods (mixed models, longitudinal analyses, simulations).
• Experience in exploratory statistical analyses to support development and decision-making.
• Strong proficiency in R; solid SAS programming; experience with CDISC, ADaM, ISS/ISE.

Responsibilities

• Lead studies and provide statistical guidance to cross-functional teams.
• Develop study protocols, design discussions, and sample size calculations.
• Perform exploratory analyses to evaluate trends and support decisions.
• Apply advanced statistical methods for efficacy and longitudinal analyses.
• Design and run simulation studies to evaluate designs and operating characteristics.
• Lead efficacy analyses and interpretation of primary and secondary endpoints.
• Review CRFs and data guidelines; develop SAPs and TLF specifications.
• Communicate statistical methodology and implications to non-technical audiences.
• Collaborate to meet project goals and timelines.
• Remain adaptable to changing priorities.

Skills

R

SAS

CDISC standards

ADaM specifications

ISS/ISE regulatory submissions

Statistical modeling

Mixed models

Longitudinal analyses

Simulation methodologies

Data visualization

Education

Master's degree in Statistics, Biostatistics, or related discipline

PhD strongly preferred

Tools

R

SAS

Job description

Cytel seeks an experienced Principal Biostatistician to lead Phase I-IV clinical studies across the region. You will develop integrated analysis plans, mentor teams, and partner with clients to advance development possibilities with rigorous statistical methodology and practical decision-making.

This role requires strong expertise in study design, mixed models, simulation, and regulatory submissions (ISS/ISE).