Principal Biostatistician

TN United Kingdom; United Kingdom; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Principal Biostatistician to lead clinical trials and contribute to study protocols. This role offers the chance to develop Statistical Analysis Plans and oversee outsourced trials, ensuring the highest quality of statistical analysis. With a commitment to continuous learning and an inclusive workplace, this opportunity promises a rewarding career in a dynamic environment. Join a team where your expertise in biostatistics will make a significant impact on clinical research and development.

Benefits

Comprehensive reward package

Competitive pay

Recognition programs

Employee benefits

Qualifications

• 5+ years of experience in CRO or pharmaceutical companies.
• Thorough knowledge of CDISC standards and regulatory requirements.

Responsibilities

• Serve as the responsible biostatistician on clinical trials.
• Develop Statistical Analysis Plans and perform quality reviews.

Skills

R programming

Leadership skills

Communication skills

Statistical Analysis Plans (SAPs)

CDISC standards

Education

PhD in Statistics/Biostatistics

Master's degree in Statistics/Biostatistics

Tools

ADaM programming

TFL programming

Job description

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Position: Principal Biostatistician

Join the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

1. Serve as the responsible biostatistician on clinical trials.
2. Contribute to clinical study protocols.
3. Develop Statistical Analysis Plans and perform senior quality review of statistical analysis plans.
4. Review and interpret results from clinical studies.
5. Provide input in the development and review of CRFs.
6. Perform lead review and QC of TFLs.
7. Review datasets specifications and datasets (ADaM).
8. Present key results.
9. Contribute to clinical study reports.
10. Review randomization specifications and schemes.
11. Oversee outsourced trials from a Biostatistics perspective.
12. Contribute to press releases and scientific papers.

You are:

• PhD in statistics, biostatistics, or related fields with 5+ years of experience OR a Master’s degree with 10+ years of experience in CRO or pharmaceutical companies.
• Thorough knowledge of CDISC standards and regulatory requirements.
• Experience with Phase 2 and 3 studies.
• Experience in R programming, ESTIMANDS, adaptive designs, and writing SAPs.
• Experience in creating analysis for publications.
• Strong leadership and communication skills.
• Knowledge of ADaM and TFL programming.

Why ICON?

We offer a comprehensive reward package, including competitive pay, variable pay, recognition programs, and employee benefits. We are committed to continuous learning and development, fostering an inclusive workplace free of discrimination. We encourage applicants to apply even if they don’t meet all requirements, as they may still be a perfect fit for this or other roles.