Senior Medical Affairs Biostatistician — Clinical Data Strategy

Cytel; Boise (ID); Sur place; USD 120 000 - 190 000; Plein temps

Résumé du poste

Cytel is seeking an experienced Principal Biostatistician with a passion for clinical development to lead Phase I‑IV studies across the region. You will collaborate with clients and cross‑functional teams, applying advanced statistical methods and driving the discipline forward.

This sponsor‑dedicated role embeds you with a pharmaceutical client, supported by Cytel, and offers an entrepreneurial environment with opportunities to contribute to study design, analysis plans, regulatory documents

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 experience working on data analysis with clinical studies databases.
• Experience working on post-approval observational and clinical studies.
• Understanding of ICH GCP as well as general knowledge of industry practices and standards.
• Experience in R programming language and other statistical software.
• Experience with CDISC, including SDTM, ADaM, CDASH.

Responsabilités

• Collaborates with Medical Affairs to design post approval studies.
• Writes the statistical sections of study protocols, while consulting with internal and external experts.
• Contributes to or prepares statistical analysis plans.
• Collaborates with Data Management and Medical Research on design of eCRFs.
• Provides statistical guidance on conduct of ongoing studies.
• Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs.
• Contributes observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.
• Contributes to scientific articles, summarizing data collected in studies.
• Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.
• Reviews abstracts, manuscripts for publications and presentations.

Connaissances

Communication skills

Presentation skills

Team collaboration

Formation

PhD in Biostatistics

MS in Biostatistics

Outils

SAS

R

CDISC (SDTM/ADaM/CDASH)

Description du poste

Cytel is seeking an experienced Principal Biostatistician with a passion for clinical development to lead Phase I‑IV studies across the region. You will collaborate with clients and cross‑functional teams, applying advanced statistical methods and driving the discipline forward.

This sponsor‑dedicated role embeds you with a pharmaceutical client, supported by Cytel, and offers an entrepreneurial environment with opportunities to contribute to study design, analysis plans, regulatory documents