JOB DESCRIPTION
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
SAS
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
All
Language
English
Hard Skills
Soft Skills
Seniority Level
Experience 5 – 10 years
Starting Date
2023-04-18
Project Duration
1 – 4 years
FTE / nb of days per week
5
Project Location
Paris-Montpellier or Full home based, France
Remote Flexibility
Yes
Travel Expected
No
Approximative Budget
Any other information of interest
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