Project 55152 – Biostatistician project leader – Several indications



Contract Type

Candidate (Freelancer)

Company Type

Consulting / CRO

Company Size

Small 100 – 1000

Requested Expertise

Biostatistics / Data management / Data Science / /

Profile Required

> 4 years of experience in CRO or Pharma (not in public)

Hard skills :
English Fluent
SAP Writing

Project Description

* Sample size or power calculations/simulations files (eg, East/SAS/R script as applicable) and documentation (eg, report/memo/respective section in the Statistical Analysis Plan (SAP) or any study document as applicable)
* Statistical section of any study document (eg, study ID card, protocol, study report)
* Statistical documentation for randomization plan and User Acceptance Test reports as applicable (eg, statistical documentation and specifications for Interactive Response Technology (IRT))
* Documentation of statistical review of study documents as applicable (eg, Case Report Form, protocol, study risk management plan, IRT specifications, study report…) or project documents as applicable
* DMC charter statistical documentation and SAP as applicable
* Statistical surveillance reports when applicable (or data surveillance reports as applicable)
* SAP and list of TL&Fs (Tables, Listings and Figures) for the study (including shell TL&Fs document for study-specific outputs) or pool of studies as applicable
* Documentation of review of SDTM/ADAM documentation (mainly derived variables)
* Documented instructions for statistical programmers
* Statistical Status at Study Team Meetings (eg, slides) as applicable
* Statistical programs in SAS or R and QC documentation
* Dry-run and final reports outputs and interpretation
* Documentation of statistical review of publications as applicable

Therapeutic Area




Hard Skills

Soft Skills

Seniority Level

Experience 5 – 10 years

Starting Date


Project Duration

1 – 4 years

FTE / nb of days per week


Project Location

Paris-Montpellier or Full home based, France

Remote Flexibility


Travel Expected


Approximative Budget

Any other information of interest

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