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Biostatistician – France

0-2 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Biostatistician – France (Full-Time, Permanent, Remote)

Excelya | Full-Time | Permanent | Remote (France-based)

Excelya, a leading European Contract Research Organization (CRO), is looking for a Biostatistician to contribute to the design, analysis, and monitoring of clinical trials. This role offers an opportunity to work with cutting-edge statistical methodologies in a dynamic and collaborative environment.

Key Responsibilities

  • Support clinical trials by collaborating with the project statistician and trial team.
  • Conduct sample size and power calculations using East, SAS, or R.
  • Develop and document the statistical section of study documents.
  • Prepare randomization plans and User Acceptance Test reports.
  • Provide statistical review for study documents and ensure compliance.
  • Generate DMC (Data Monitoring Committee) statistical documentation and SAP.
  • Deliver statistical surveillance reports for ongoing trials.
  • Develop SAPs and define Tables, Listings, and Figures (TL&Fs).
  • Review SDTM/ADAM documentation to ensure high-quality datasets.
  • Write and debug statistical programs in SAS or R with proper QC documentation.

Minimum Requirements

  • Degree in Statistics, Computer Science, or a relevant field.
  • Experience as a Biostatistician in a biotech, CRO, or pharmaceutical company.
  • Proficiency in SAS programming (base SAS, SAS macros, SAS/STAT) with debugging expertise.
  • Experience with SDTMs, ADaM datasets, and TL&Fs.
  • Prior oncology data analysis experience (safety & efficacy) preferred.
  • Strong ability to communicate statistical concepts effectively.
  • Fluent in English (business level).
  • Remote work allowed, but must be based in France.

This is a great opportunity for an experienced Biostatistician to play a crucial role in clinical trials and contribute to advancing healthcare.