Lead Biostatistician - late-stage drug development

VGS RPO Services; United Kingdom; Remote; GBP 110,000 - 150,000; Full time

Job summary

VGS RPO Services in the United Kingdom is seeking a senior biostatistician to shape drug development strategy and lead statistical input across Phase II/III trials.

You will drive regulatory submissions with SAS and R, oversee CRO statistical activities, and collaborate with clinical teams and regulators across the UK and Europe.

Qualifications

• PhD or MSc in Statistics/Biostatistics required.
• 8–10 years' biostatistics experience in pharma or CRO.
• Lead biostatistical activities in late-stage development and regulatory submissions.
• Experience overseeing CRO statistics is essential.

Responsibilities

• Provide statistical leadership across Phase II/III and late-stage clinical trials.
• Lead statistical strategy for pivotal studies and regulatory submissions.
• Influence study design, protocols and development plans.
• Collaborate with clinical, medical and cross-functional teams.
• Support FDA, EMA and MHRA regulatory interactions.
• Oversee outsourced statistical activities including SAPs, TFLs and Blind Data Reviews.
• Contribute to integrated analyses, publications and scientific discussions.

Skills

Biostatistics leadership

Late-stage development

Regulatory submissions

SAS

R

CRO oversight

CDISC standards

Clinical trial methodology

Education

MSc or PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

Highly competitive remuneration | Remote working | Global pharmaceutical business

Applications welcomed from experienced professionals based in the UK and surrounding European locations.

An exciting opportunity to shape the future of drug development

Join an ambitious, rapidly growing and innovations-led global pharmaceutical business combining the scientific reach of an established organisation with the collaborative, entrepreneurial culture of a close-knit team. This is a senior, influential role where you will help shape clinical development strategy, lead statistical input into pivotal studies and support regulatory submissions and drug approvals.

The role

• Provide statistical leadership across Phase II/III and late-stage clinical trials.
• Lead statistical strategy for pivotal studies and regulatory submissions.
• Influence study design, protocols and clinical development plans.
• Work closely with clinical, medical and cross-functional teams.
• Support FDA, EMA and MHRA regulatory interactions.
• Oversee outsourced statistical activities, including SAPs, TFLs and Blind Data Reviews.
• Contribute to integrated analyses, publications and scientific discussions.

About You

• MSc or PhD in Statistics, Biostatistics or a related discipline.
• 8–10 years' biostatistics experience within pharma or CRO environments.
• Strong experience in late-stage clinical development and regulatory submissions.
• Proven experience in a lead biostatistical role.
• Excellent knowledge of clinical trial methodology, statistical modelling and CDISC standards.
• Experience overseeing CRO statistical activities.
• Expert proficiency in SAS and/or R.

Why consider this position

• A genuinely supportive, entrepreneurial and people-focused culture.
• Highly competitive remuneration & career development opportunities.
• Senior-level influence over clinical development strategy.
• International collaboration across multiple therapeutic areas.