Lead Principal Statistician, Clinical Trials & Analytics

BioSpace; Palo Alto (CA); On-site; USD 156,000 - 234,000; Full time

Job summary

Jazz Pharmaceuticals is seeking a Senior Principal Statistician, Biostatistics, to lead the statistical design and analysis for Phase I–IV studies and regulatory filings under supervision. This role requires collaboration with clinical development, pharmacology, clinical operations, and medical writing, and will involve managing external vendors.

The candidate will develop statistical strategy, design analyses, and oversee validation of results, ensuring high-quality deliverables for regulatory

Qualifications

• Knowledge of clinical trial design and analysis, including complex statistical methods and models.
• Experience in using SAS and R; knowledge of other statistical applications a plus.
• Knowledge of regulatory requirements and CDISC standards.

Responsibilities

• Lead statistical design and analysis for Phase I–IV studies and regulatory filings.
• Provide statistically sound analyses and develop analysis plans.
• Collaborate with cross‑functional teams and manage CROs and vendors.

Skills

Clinical trial design

Statistical analysis

SAS

R

CDISC standards

Regulatory knowledge

Education

MS or MPH in statistics

PhD in statistics

Tools

SAS

R

Job description

Jazz Pharmaceuticals is seeking a Senior Principal Statistician, Biostatistics, to lead the statistical design and analysis for Phase I–IV studies and regulatory filings under supervision. This role requires collaboration with clinical development, pharmacology, clinical operations, and medical writing, and will involve managing external vendors.

The candidate will develop statistical strategy, design analyses, and oversee validation of results, ensuring high-quality deliverables for regulatory