Senior Medical Affairs Biostatistician - Post-Approval Studies

Cytel; Hagåtña (GU); Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Cytel seeks an experienced Principal Biostatistician to lead Phase I-IV studies across the region, driving advanced analyses and methodological leadership. You will motivate teams, collaborate with clients, and push forward innovative drug development.

The role emphasizes autonomous, entrepreneurial work within Medical Affairs and cross-functional teams. You will be embedded with a pharmaceutical client, shaping study designs, analysis plans, and interpretation of results while leveraging

Qualifikationen

• PhD in Biostatistics, Statistics, or equivalent with at least 5 years pharmaceutical biostatistics experience; or MS with at least 8 years' relevant experience.
• Excellent written and oral communication and presentation skills.
• Extensive experience programming in SAS.
• Experience with data analysis from clinical studies databases.
• Experience with post-approval observational and clinical studies.
• Understanding of ICH GCP and industry practices and standards.
• Experience with R and CDISC standards.

Aufgaben

• Collaborates with Medical Affairs to design post-approval studies.
• Writes the statistical sections of study protocols and analysis plans.
• Contributes to or prepares statistical analysis plans.
• Collaborates with Data Management on eCRF design.
• Provides statistical guidance on ongoing studies.
• Accounts for collaboration with Statistical Programming for analyses.
• Contributes to observational study reports and regulatory documents.
• Contributes to scientific articles and presentations.

Kenntnisse

Statistical analysis

SAS programming

R programming

Communication skills

Collaboration

Ausbildung

PhD in Biostatistics or equivalent

MS in Biostatistics

Tools

SAS

R

CDISC (SDTM/ADaM/CDASH)

Jobbeschreibung

Cytel seeks an experienced Principal Biostatistician to lead Phase I-IV studies across the region, driving advanced analyses and methodological leadership. You will motivate teams, collaborate with clients, and push forward innovative drug development.

The role emphasizes autonomous, entrepreneurial work within Medical Affairs and cross-functional teams. You will be embedded with a pharmaceutical client, shaping study designs, analysis plans, and interpretation of results while leveraging