Job Details
FSP Principal Biostatistician – Early Phase Clinical Development (PK)
6010
Posted: 30/10/2025
- £Competitive
- Home Based - US / Canada, United States
- Permanent
FSP Principal Biostatistician – Early Phase Clinical Development (PK) | Home-based U.S. / Canada | Permanent |
We are working with a leading global CRO who have an opportunity within their FSP team for a Senior or Principal Biostatistician to provide statistical support for early-phase drug development programs, focusing on healthy volunteer studies with PK and PD endpoints.
Key Responsibilities:
What you will need:
Why Join:
What to do next?
If this opportunity is of interest, please apply now with your CV as they are looking to arrange interviews soon.
We are working with a leading global CRO who have an opportunity within their FSP team for a Senior or Principal Biostatistician to provide statistical support for early-phase drug development programs, focusing on healthy volunteer studies with PK and PD endpoints.
Key Responsibilities:
- Collaborate with multidisciplinary teams to define project timelines and deliverables.
- Provide statistical input for study synopses, protocols, and sample size calculations.
- Author and review statistical sections of protocols, SAPs, datasets, and TLF specifications.
- Review eCRFs and other data management documentation.
- Develop or review randomizations and related specifications.
- Guide and supervise programmers in dataset creation and generation of tables, listings, and figures.
- Conduct statistical analyses and validate key data derivations using SAS and/or R.
- Interpret study results and ensure accuracy of study reports.
- Monitor internal and CRO activities to ensure timelines, quality, and resource availability.
- Collaborate with Clinical Development, Data Management, and Clinical Pharmacology/PK teams.
- Contribute to clinical study reports and regulatory documents (e.g., DSURs, IB).
- Support exploratory analyses and, where applicable, IND activities.
What you will need:
- Ph.D. in Statistics, Biostatistics, or related field with 3+ years of experience, or M.S. with 5+ years.
- Minimum 2 years of experience with non-compartmental PK analysis.
- Knowledge of ICH GCP, regulatory guidance, and CDISC standards (SDTM, ADaM, CDASH).
- Strong SAS skills and ability to manage multiple projects independently.
- Excellent communication and leadership abilities.
- Familiarity with statistical modeling, simulations, and PD/biomarker analyses.
- Must have U.S. or Canadian passport or permanent resident (green card) status to apply.
Why Join:
- Home-based remote working opportunities.
- Research opportunities that match your unique skillset.
- Promising career trajectory with technical training and tailored development plan.
- Job stability - long-term engagements and re-deployment opportunities.
- Focus on bringing new therapies to market.
- Engaging, fast-paced environment.
- Good work-life balance and flexible schedules.
What to do next?
If this opportunity is of interest, please apply now with your CV as they are looking to arrange interviews soon.
Aimee Weston
Principal Consultant in Biostatistics
Apply for this role
Recruitment