Senior Biostatistician — Clinical Development Lead

Cytel Inc

City of Westminster

On-site

GBP 70,000 - 100,000

Full time

7 days ago

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Job summary

Cytel Inc. is seeking a Senior Biostatistician to support multiple clinical studies, design discussions and SAP development. You will lead analyses, interpret results and prepare integrated summaries for regulatory submissions, while collaborating with CROs and biotech partners.

The role requires a Master’s in statistics with 5+ years of trials experience; a PhD is strongly desired, and SAS/R proficiency is expected. Regulatory awareness and strong communication are essential.

Qualifications

5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
Experience working for a CRO is strongly desired.
Experience in protocol concept development, SAP, and CDS for submissions.
Good SAS programming skills for QCing outputs and tables; R a plus.
Solid understanding of CDISC and ADaM specifications.

Responsibilities

Providing statistical support to clinical studies.
Developing study protocols, design discussions and sample size calculations.
Reviewing CRFs and data review guidelines; creating SAPs and data specs.
Conducting statistical analyses and interpreting results.
Preparing clinical study reports including integrated summaries for submissions.
Communicating methodology and decisions clearly to stakeholders.
Collaborating with CROs, vendors and clinical partners to meet timelines.