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Biostatistician

2+ years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

We offer a personal and authentic experience within a young, ambitious health company, on a mission to become the clinical research leader in Europe with the help of our 800 Excelyates. Our unique, one-stop provider service model – combining full-service, functional service provision, and consulting – allows our Excelyates to grow through a variety of projects. In partnership with leading experts, Excelya advances scientific, managerial, and human knowledge to enhance the patient journey.

For our team members, excelling with care means thriving in a dynamic professional environment that fosters personal, intellectual, and operational growth. Together, we aim to be the best in our field. We are committed to empowering each Excelyate to unleash their natural talents, achieve their full potential, and contribute their unique abilities to our collective success.

What we offer:

Contribute to the set-up and monitoring of clinical trials in collaboration with the project statistician and clinical trial team:

  • Sample size or power calculations/simulations (e.g., East/SAS/R script as applicable) and documentation
  • Statistical section of any study document
  • Statistical documentation for randomization plan and User Acceptance Test reports
  • Documentation of statistical review of study documents
  • DMC charter statistical documentation and SAP
  • Statistical surveillance reports
  • SAP and list of TL&Fs (Tables, Listings, and Figures) for the study
  • Documentation of review of SDTM/ADaM documentation
  • Statistical programs in SAS or R and QC documentation

Minimum Requirements:

  • Degree in a relevant field such as statistics, computer science, or related discipline
  • Experience as a Biostatistician within a biotech, CRO, or pharmaceutical company
  • In-depth knowledge of base SAS, SAS macros, SAS/STAT; ability to debug SAS programs
  • Proven professional experience with SDTM, ADaM datasets, and TFLs
  • Prior experience working with oncology data (safety and efficacy) is preferred
  • Strong communication skills to effectively convey statistical concepts
  • Business fluency in English

The position is based in France (remote).