Associate Director, Biostatistics – Clinical Trials Leader

Cytel; Honolulu (HI); On-site; USD 150,000 - 210,000; Full time

Job summary

Cytel is seeking an Associate Director of Biostatistics to be embedded with a major Pharma client, supporting or leading clinical trials and applying advanced statistics.

You will use SAS or R for analyses, collaborate with cross-functional teams, and influence regulatory submissions across Phases 2-3. The role requires strong communication and leadership within Cytel's Global Therapeutic Statistics group.

Qualifications

• Master's degree in Statistics or related quantitative discipline; PhD preferred.
• 7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry.
• Strong knowledge of adaptive design, group sequential and statistical methods of count data.
• Prior Hematology studies experience preferred.
• Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations for clinical trials and submissions.
• Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams.
• Excellent and effective communication skills and ability to interact with cross-functional stakeholders.

Responsibilities

• Lead statistical activities for assigned Clinical Trials (Phases 2-3) from protocol design to reporting of results.
• Represent Statistics on cross-functional trial teams and collaborate with stakeholders.
• Oversee internal programming activities and CRO contributions on trials.
• Contribute to or lead activities from a statistical perspective including database lock and submissions.
• Develop and finalize study outputs in line with regulatory requirements.
• Use SAS and/or R for QC, inferential analyses, modelling and exploratory analyses.
• Coordinate statistical activities across studies within the project to ensure on-time delivery.

Skills

Communication skills

Organizational skills

Project management

Independent work

Education

Master’s degree in Statistics or related quantitative discipline

PhD preferred

Tools

SAS

R

Job description

Cytel is seeking an Associate Director of Biostatistics to be embedded with a major Pharma client, supporting or leading clinical trials and applying advanced statistics.

You will use SAS or R for analyses, collaborate with cross-functional teams, and influence regulatory submissions across Phases 2-3. The role requires strong communication and leadership within Cytel's Global Therapeutic Statistics group.