Senior Principal Statistician

EPM Scientific; France; On-site; EUR 110,000 - 145,000; Full time

Job summary

EPM Scientific is seeking an experienced Senior Principal Statistician to drive statistical strategy across clinical development, from early-phase studies through registration. You will design, analyze, and report trials in collaboration with cross-functional teams in a highly dynamic environment.

Responsibilities include SAP authoring, regulatory interactions, and oversight of external CROs to ensure timely, high-quality analyses in line with ICH/CDISC standards.

Qualifications

• Advanced degree in statistics or biostatistics with PhD/ MSc/ MPH.
• Experience supporting clinical development programmes in pharma/biotech.
• Strong knowledge of clinical trial design and statistical methodology across Phases I–IV.
• Hands-on SAS and R coding experience.
• Understanding of ICH guidelines, regulatory requirements, and CDISC standards.
• Experience preparing statistical components of regulatory submissions.

Responsibilities

• Lead statistical activities for Phase I–IV studies, integrated analyses, and regulatory submissions.
• Provide strategic input into study design, endpoints, sample size, and analysis plans.
• Author and review Statistical Analysis Plans (SAPs).
• Oversee analyses, validation, and interpretation of results.
• Collaborate with Clinical Development, Data Management, Regulatory Affairs, Medical Writing, and Project Management teams.

Skills

Statistical leadership

Project management

Stakeholder communication

Education

MSc/ MPH/ PhD in Statistics or Biostatistics

Tools

SAS

R

Job description

We are partnering with an innovative biopharmaceutical organisation seeking an experienced Senior Principal Statistician to play a key role in the design, analysis, and reporting of clinical trials across the development lifecycle.

This is an opportunity to work within a highly collaborative environment, partnering with cross-functional teams to shape statistical strategy, support regulatory submissions, and influence clinical development decisions from early-phase studies through to registration.

Key Responsibilities

We are partnering with an innovative biopharmaceutical organisation seeking an experienced Senior Principal Statistician to play a key role in the design, analysis, and reporting of clinical trials across the development lifecycle.

This is an opportunity to work within a highly collaborative environment, partnering with cross-functional teams to shape statistical strategy, support regulatory submissions, and influence clinical development decisions from early-phase studies through to registration.

Key Responsibilities

• Lead statistical activities for Phase I-IV clinical studies, integrated analyses, and regulatory submissions.
• Provide strategic input into study design, endpoints, sample size determination, and analysis methodology.
• Author and review Statistical Analysis Plans (SAPs).
• Oversee statistical analyses, validation activities, and interpretation of study results.
• Collaborate closely with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Pharmacovigilance, Medical Writing, and Project Management teams.
• Represent statistics in cross-functional study teams and governance discussions.
• Contribute to interactions with regulatory authorities and support responses to regulatory questions.
• Manage and oversee external CROs and statistical programming vendors, ensuring quality and timely delivery.
• Support the development and implementation of statistical standards, processes, and best practices.
  

Required Experience

• MSc, MPH, PhD, or equivalent in Statistics, Biostatistics, Mathematics, or a related quantitative discipline.
• Experience supporting clinical development programmes within a pharmaceutical or biotechnology environment.
• Strong knowledge of clinical trial design, statistical methodology, and data analysis across Phases I-IV.
• Hands-on experience with SAS and R.
• Understanding of ICH guidelines, regulatory requirements, and CDISC standards.
• Experience preparing statistical components of regulatory submissions.
• Ability to manage multiple projects in a fast-paced and collaborative environment.
• Excellent communication and stakeholder management skills.