Senior Principal Biostatistician, Clinical Trials Lead

Jazz Pharmaceuticals; Cambridge; On-site; GBP 85,000 - 120,000; Full time

Job summary

Jazz Pharmaceuticals in Cambridge is seeking a Senior Principal Statistician, Biostatistics, to lead statistical work on Phase I–IV studies and regulatory filings.

You will design analyses, develop statistical strategy, and collaborate with clinical, regulatory, medical writing, and data management teams. Experience with SAS, R, CDISC standards, and strong communication are essential; PhD or MS with relevant experience preferred.

Qualifications

• MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 4 years of experience in pharmaceutical or biotechnology industry.
• PhD in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry.
• Knowledge of drug development regulations pertinent to statistical analysis.

Responsibilities

• Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
• Collaborate with cross-functional team members to meet study timelines.
• Support the development and implementation of study protocols.
• Review and provide input to data capture systems and participate in their validation.
• Develop statistical programs to simulate trial design operating characteristics and perform analyses.
• Write statistical analysis plans and oversee data analyses and validation.
• Prepare for and attend meetings with regulatory agencies.
• Work with biostatistics leads and management to maintain department standards.
• Review CRO timelines and deliverables for timeliness and quality.
• Act as the statistical subject matter expert in producing clinical reports and integrated summaries.
• Respond to statistical questions from regulatory agencies.

Skills

SAS

R

Statistical analysis

Study design

Education

MS or MPH in statistics or related field

PhD in statistics or related field

Tools

CDISC standards

Job description

Jazz Pharmaceuticals in Cambridge is seeking a Senior Principal Statistician, Biostatistics, to lead statistical work on Phase I–IV studies and regulatory filings.

You will design analyses, develop statistical strategy, and collaborate with clinical, regulatory, medical writing, and data management teams. Experience with SAS, R, CDISC standards, and strong communication are essential; PhD or MS with relevant experience preferred.