Senior Medical Affairs Biostatistician – Post-Approval Studies

Cytel; Augusta (ME); On-site; USD 180,000 - 240,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead Phase I–IV clinical studies across the U.S. and work embedded within a sponsor client, with Cytel backing.

You will contribute to study designs, analysis plans, and regulatory documents while guiding teams and collaborating with medical affairs, publications, and statistics colleagues. You are a proactive leader with strong SAS and R skills, CDISC experience, and deep knowledge of ICH GCP, ready to drive drug development forward

Qualifications

• 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.
• Extensive experiences working on data analysis with clinical studies database.
• Experience working on post-approval observational and clinical studies.
• Understanding of ICH GCP as well as general knowledge of industry practices and standards.
• Experiences in R programming language and CDISC CDASH/SDTM/ADaM.

Responsibilities

• 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.
• Leads collaboration with Statistical Programming for analysis of all data.
• Contributes to observational study reports and regulatory documents.
• Participates in publications and presentations.
• Reviews abstracts and manuscripts for publications.

Skills

SAS programming

R programming

ICH GCP knowledge

Education

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

R

CDISC SDTM/ADaM/CDASH

Job description

Cytel is seeking an experienced Principal Biostatistician to lead Phase I–IV clinical studies across the U.S. and work embedded within a sponsor client, with Cytel backing.

You will contribute to study designs, analysis plans, and regulatory documents while guiding teams and collaborating with medical affairs, publications, and statistics colleagues. You are a proactive leader with strong SAS and R skills, CDISC experience, and deep knowledge of ICH GCP, ready to drive drug development forward