Senior Regulatory Re - Cambridge, Cambridgeshire, United Kingdom - AL Solutions

Description

Ashley Smith-Brown is working with a clinical stage Biotech with two ground-breaking compounds in phase 3 trials, poised to revolutionize patient care and bring life-changing therapies to market.

As part of their continued growth and commitment to excellence, they are actively seeking a talented and experienced Senior/Principal Biostatistician to join their dynamic team based in Cambridge, UK.

Position:
Senior/Principal Biostatistician

Collaborate with cross-functional teams to design, develop, and implement statistical methodologies for clinical trials, ensuring the highest scientific rigor.

Provide expert guidance on statistical strategies, data analysis plans, and clinical trial protocols to optimize trial design and ensure data integrity.

Perform sophisticated statistical analyses on clinical trial data, contributing to regulatory submissions and publications.
Support ongoing clinical development activities, including interim and final analyses, safety reviews, and data monitoring committee interactions.
Act as a statistical consultant for internal and external stakeholders, including investigators, regulatory authorities, and CROs.
D. or Master's degree in Biostatistics, Statistics, or a related field.
Proven experience as a Biostatistician in the pharmaceutical or biotechnology industry, ideally supporting phase 3 clinical trials.
Proficiency in statistical software such as SAS, R, or Python.
Strong knowledge of regulatory requirements and guidelines for clinical trials (ICH-GCP, FDA, EMA).
Competitive salary with performance-based bonus structure.
Comprehensive health and wellness benefits package.
Professional development opportunities to enhance your skillset and career growth.

We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If this position doesn't interest you, please visit our website for a list of more vacancies.