Senior Biostatistician, Medical Affairs & Post-Approval Studies

Cytel; Dover (DE); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Cytel in the United States is seeking an experienced Principal Biostatistician to lead Phase I–IV studies within your region. You will design and analyze trials, mentor teams, and partner with clients to advance drug development.

As a sponsor-dedicated Medical Affairs Biostatistician, you will craft statistical sections of protocols, analysis plans, and reports, collaborate across Medical Affairs, Regulatory, and Data Management, and contribute to scientific publications.

Qualifikationen

• PhD/MS with strong pharma biostatistics experience.
• Proven expertise in SAS programming.
• Experience with CDISC SDTM/ADaM standards.
• Excellent communication and collaboration skills.

Aufgaben

• Collaborate with Medical Affairs and other teams to design post-approval studies.
• Write statistical sections of study protocols and analysis plans.
• Contribute to statistical analysis plans and data reviews.
• Support observational studies and regulatory documentation.
• Provide statistical guidance during ongoing studies.

Kenntnisse

SAS programming

R programming

CDISC SDTM

ICH GCP

Study design

Ausbildung

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

R

CDISC SDTM

Jobbeschreibung

Cytel in the United States is seeking an experienced Principal Biostatistician to lead Phase I–IV studies within your region. You will design and analyze trials, mentor teams, and partner with clients to advance drug development.

As a sponsor-dedicated Medical Affairs Biostatistician, you will craft statistical sections of protocols, analysis plans, and reports, collaborate across Medical Affairs, Regulatory, and Data Management, and contribute to scientific publications.