Senior Principal Statistician — Early Ophthalmology Trials

1201 F. Hoffmann-La Roche AG

Basel

On-site

CHF 150,000 - 210,000

Full time

3 days ago

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Job summary

Roche is seeking a Principal Statistician in Early Development to lead statistical design and analysis for first-in-human and early-phase studies. You will collaborate across Biostatistics, Analytical Data Science, and Data Management to enable data-driven decisions and robust regulatory submissions.

Mentoring and innovative statistical approaches are central to the role. You will partner with ophthalmology and immunology teams, contribute to complex trial designs, and shape the statistical

Qualifications

PhD or MSc in Statistics, Biostatistics, or closely related field.
6+ years in clinical trial statistics, Phase 1/2 experience preferred.
Strong leadership in cross-functional teams and regulatory submissions.
Proficiency in R (preferably with SAS) and familiarity with CDISC standards.

Responsibilities

Contribute to protocol design and develop SAP/CSR.
Analyse complex data to inform early go/no-go decisions and regulatory interactions.
Lead statistical framework design for early phase programmes and regulatory submissions.
Mentor junior statisticians and provide cross-functional leadership within the team.

Skills

Statistical leadership

Clinical trial statistics

Mentoring

Adaptive/Bayesian designs

R & SAS

CDISC standards

Communication

Cross-functional collaboration

Education

PhD/MSc in Statistics/Biostatistics

Tools

SAS

CDISC standards

Job description

Mentoring and innovative statistical approaches are central to the role. You will partner with ophthalmology and immunology teams, contribute to complex trial designs, and shape the statistical

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