Senior Statisitcal Programmer
About the role
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- 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.
- Develop advanced MACROs
- Master degree in Computer Science or similar
- Highly experienced as a SAS Programmer in the pharmaceutical industry.
- Work experience as a SAS programmer in UK and India to liaise between both teams.
- Working knowledge of CDISC data standards including ADaM and SDTM is a must.
- Excellent skills in BASE/SAS, SAS/SQL, SAS/MACROS, SAS/ODS and SAS/STAT in a Windows environment.
- Proven experience in development of advanced MACROs (such as MACROs to support analysis data set and TFL creation) with high programming efficiency.
- Deep understanding of the programming and validation/QC process (inputs, requirements, specifications).
- 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.
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