Senior Medical Affairs Biostatistician — Lead Clinical Analytics

Cytel; Carson City (NV); Vor Ort; USD 150.000 - 230.000; Vollzeit

Zusammenfassung

Cytel is seeking a Medical Affairs Biostatistician to lead statistical activities for Medical Affairs across Phase I–IV studies. You will contribute to study design, analysis plans, and data interpretation, collaborating with Medical Affairs, Publications and Regulatory teams.

You will design post-approval studies, review analyses, and produce statistical reports while guiding eCRF design and CDISC standards. An entrepreneurial mindset is valued.

Qualifikationen

• PhD (or MS with 8+ years) in Biostatistics or related field and pharmaceutical biostatistics experience.
• Excellent written and oral communication and presentation skills.
• Extensive experience programming in SAS.
• Experience with data analysis in clinical studies databases.
• Experience with post-approval observational and clinical studies.
• Understanding of ICH GCP and industry standards.
• Proficiency in R and other statistical software.
• Experience with CDISC standards (SDTM, ADaM, CDASH).

Aufgaben

• Collaborates with Medical Affairs, Medical Communications and Publications, Epidemiology and Regulatory to design post approval studies.
• Writes the statistical sections of study protocols, consulting with internal and external experts.
• 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 to implement analyses for clinical trials, registries and observational data.
• Contributes to scientific articles and briefing documents.
• Participates in meetings to support Biostatistics and Medical Affairs.
• Reviews abstracts and manuscripts for publications and presentations.

Kenntnisse

SAS programming

R programming

Statistical analysis

Clinical data analysis

Presentation skills

Collaboration

Ausbildung

PhD in Biostatistics, Statistics, or equivalent

MS in Biostatistics or related field

Tools

SAS

CDISC (SDTM/ADaM/CDASH)

Jobbeschreibung

Cytel is seeking a Medical Affairs Biostatistician to lead statistical activities for Medical Affairs across Phase I–IV studies. You will contribute to study design, analysis plans, and data interpretation, collaborating with Medical Affairs, Publications and Regulatory teams.

You will design post-approval studies, review analyses, and produce statistical reports while guiding eCRF design and CDISC standards. An entrepreneurial mindset is valued.