Senior Medical Affairs Biostatistician Post Approval Analytics

Cytel; Cheyenne (WY); On-site; USD 120,000 - 170,000; Full time

Job summary

Cytel Inc. is seeking an experienced Principal Biostatistician to lead statistical activities across multiple clinical studies in a sponsor-dedicated role.

You will design and analyze post-approval and observational studies, write statistical sections of protocols, and collaborate with cross-functional teams to advance drug development. The role emphasizes SAS and R programming, CDISC standards, and strong communication skills.

Qualifications

• PhD in Biostatistics, Statistics, or equivalent required; or MS with 8+ years pharma biostatistics experience.
• Excellent written and oral communication and presentation skills.
• Extensive experience programming in SAS.
• Extensive experience working with clinical studies databases.
• Experience working on post-approval observational and clinical studies.
• Understanding of ICH GCP and general industry practices.
• Experience with R programming language.
• Experience with CDISC standards (SDTM, ADaM, CDASH).

Responsibilities

• Collaborates with Medical Affairs, Medical Communications, and Epidemiology to design post-approval studies.
• Writes the statistical sections of study protocols in consultation with experts.
• Contributes to or prepares statistical analysis plans.
• Collaborates with Data Management on eCRF design.
• Provides statistical guidance on ongoing studies.
• Supports Statistical Programming to implement analyses for all trial data.
• Contributes to observational study reports and regulatory documents.
• Contributes to scientific articles and abstracts.

Skills

Communication skills

SAS programming

R programming

Clinical data analysis

Team collaboration

Education

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

CDISC SDTM/ADaM/CDASH

R

Job description

Cytel Inc. is seeking an experienced Principal Biostatistician to lead statistical activities across multiple clinical studies in a sponsor-dedicated role.

You will design and analyze post-approval and observational studies, write statistical sections of protocols, and collaborate with cross-functional teams to advance drug development. The role emphasizes SAS and R programming, CDISC standards, and strong communication skills.