Principal Biostatistician — Lead Global Clinical Trials

Cytel; Atlanta (GA); On-site; USD 150,000 - 210,000; Full time

Job summary

Cytel in Atlanta, GA seeks an experienced Principal Biostatistician to lead Phase I–IV clinical studies, applying advanced methods and ML to derive actionable insights. You will guide study design, analyses, and regulatory deliverables while collaborating with clients and cross-functional teams.

You will mentor teams, review SAPs and ISS/ISEs, perform simulations, and communicate complex statistics in clear language.

Qualifications

• Master's degree in Statistics, Biostatistics, or related discipline; PhD preferred.
• 8-10 years biostatistics experience in pharma/biotech; CRO experience preferred.
• 3-5 years Study Lead experience with cross-functional development teams.
• Strong knowledge of CDISC, ICH guidelines and regulatory expectations.
• Proficiency in R and SAS for analyses and reporting.

Responsibilities

• Lead Phase I–IV studies and provide statistical guidance to teams.
• Develop SAPs, ISS/ISEs, and analysis datasets for submissions.
• Design studies, determine sample sizes, and run simulations.
• Present statistical results to non-technical stakeholders clearly.
• Collaborate with cross-functional teams and clients to meet timelines.

Skills

R programming

SAS programming

Communication skills

Study Lead leadership

Education

Master's degree in Statistics/Biostatistics

PhD preferred

Tools

R

SAS

Job description

Cytel in Atlanta, GA seeks an experienced Principal Biostatistician to lead Phase I–IV clinical studies, applying advanced methods and ML to derive actionable insights. You will guide study design, analyses, and regulatory deliverables while collaborating with clients and cross-functional teams.

You will mentor teams, review SAPs and ISS/ISEs, perform simulations, and communicate complex statistics in clear language.