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Statistical Programmer M/W
At least 5 years previous clinical
Our client is a leading provider of global resourcing solutions
About Our Client
Our client is a leading provider of global resourcing solutions to the biopharmaceutical and medical device industries. Several open roles !
Responsible for statistical programming will include but are not limited to the following:
- Provide programming input to CRF, SAP, analysis file specifications, tables, figures, listings (TFLs) shells.
- Write SAS programs to generate derived analysis data sets, perform analysis and TFLs.
- Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
- Perform programming validation to ensure quality of analysis data sets and programming outputs.
- Provide comments to the design and checking of clinical trial database for proper data capture and data quality.
- Create Data Definition Tables (DDT) and convert TFLs to required format for eSubmission.
- Convert, check and integrate multiple sources of incoming data into the creation of analysis data sets.
These positions are home based in France, Spain, Italy, Portugal, Turkey or Greece.
The Successful Applicant
- At least 5 years previous clinical programming experience for junior level. More for higher level positions (above 7 years).
- Proven experience in development of advanced MACROs (such as MACROs to support analysis data set and TFL creation) with high programming efficiency.
- Working experience in pooling analysis datasets across multiple clinical studies (or equivalent).
- Demonstrated skills in developing data sets and TFLs in line with sponsor specifications.
- Working knowledge of database design/structures and basic statistics.
- Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
- Strong knowledge of / experience with SAS and other relevant programming software (R, SPSS, …).
- Working knowledge of CDISC data standards including ADaM and SDTM.
- Fluent English (oral and written).
What's on Offer