Biostatistician
Posted 4 days ago by ea Change
£46 Per hour
Outside
Remote
England, United Kingdom
Summary: The Biostatistician role focuses on supporting late-stage clinical development in diabetes and obesity for an innovative biotech company. This fully remote contract position involves shaping statistical strategies and delivering outputs for regulatory submissions. The candidate will lead statistical activities for Phase 2 and Phase 3 trials, ensuring high-quality analysis and reporting. The role requires collaboration with cross-functional teams to support clinical development decisions.
Key Responsibilities:
- Provide statistical expertise for end-of-Phase 2 activities, including dose selection, study design, and regulatory meeting preparation.
- Lead statistical activities for Phase 3 clinical trials, including Statistical Analysis Plan (SAP) development, randomisation strategy, interim analyses, and final study reporting.
- Contribute to and review Clinical Study Reports (CSRs) and Integrated Summaries of Efficacy (ISE) for regulatory submissions.
- Support protocol development through endpoint definition, sample size estimation, and power calculations.
- Collaborate cross-functionally with clinical, data management, and statistical programming teams.
- Provide statistical input into Clinical Development Plans (CDPs) and Target Product Profiles (TPPs).
Key Skills:
- MSc or PhD in Statistics, Biostatistics, or related quantitative discipline.
- 4–6+ years’ experience in a pharmaceutical or CRO environment.
- Direct experience working on diabetes and/or obesity clinical trials.
- Strong exposure to end-of-Phase 2 and Phase 3 clinical development.
- Proficiency in SAS and/or R.
- Familiarity with CDISC standards (SDTM, ADaM).
- Strong understanding of ICH E9(R1) estimands framework.
- Nice-to-Have: Experience supporting cardiovascular outcomes trials (CVOTs) and knowledge of metabolic clinical endpoints.
Salary (Rate): £46.00/hr
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Biostatistician – Diabetes & Obesity (Contract)
Location: Fully Remote (UK Based)
Contract Length: 6-Months
Rate: £350 per day
Outside IR35
Industry: Biotech
The Role
We are partnering with an innovative biotech company developing therapies in the diabetes and obesity space. They are seeking an experienced Biostatistician to support late-stage clinical development across Phase 2 and Phase 3 programmes. This is a fully remote contract role where you will play a key role in shaping statistical strategy, delivering high-quality outputs to support regulatory submissions and clinical development decisions.
What you will be doing:
- Provide statistical expertise for end-of-Phase 2 activities, including dose selection, study design and regulatory meeting preparation (FDA Type B/C meetings and EMA scientific advice)
- Lead statistical activities for Phase 3 clinical trials, including:
- Statistical Analysis Plan (SAP) development
- Randomisation strategy
- Interim analyses
- Final study reporting
- Contribute to and review Clinical Study Reports (CSRs) and Integrated Summaries of Efficacy (ISE) for regulatory submissions
- Support protocol development through endpoint definition, sample size estimation, and power calculations
- Collaborate cross-functionally with clinical, data management, and statistical programming teams
- Provide statistical input into Clinical Development Plans (CDPs) and Target Product Profiles (TPPs)
What you will need to have:
- MSc or PhD in Statistics, Biostatistics, or related quantitative discipline
- 4–6+ years’ experience in a pharmaceutical or CRO environment
- Direct experience working on diabetes and/or obesity clinical trials
- Strong exposure to end-of-Phase 2 and Phase 3 clinical development
- Proficiency in SAS and/or R
- Familiarity with CDISC standards (SDTM, ADaM)
- Strong understanding of ICH E9(R1) estimands framework
Nice-to-Have:
- Experience supporting cardiovascular outcomes trials (CVOTs)
- Knowledge of metabolic clinical endpoints