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Senior Statistical Programmer
Everest Clinical ResearchSenior Statistical Programmer overseeing statistical programming tasks and project management in global clinical operations. Seeking skilled professionals to join a growing biometrics team in Poland.
About the role
Key responsibilities & impact- Lead efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables, as well as improving the efficiency and productivity of statistical programming work
- Lead assigned projects by applying project management skills and statistical programming techniques; achieve on-time delivery of deliverables with quality, as well as earn client’s trust and repeat business
- Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project specific requirements
- Perform quality control (QC) review of these documents prepared by others
- Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE
- Perform CDISC standard compliant checks on SDTM and ADaM datasets
- Generate, review, and resolve Pinnacle 21 validation issues
- Perform additional QC checks on these deliverables using company Working Instruction (WI) QC checklists
- Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client
- Create SDTM and ADaM define.xml files
- Perform QC review of these files prepared by others
- Participate and/or lead programming teams in support of product regulatory submission related activities
- Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers
- Develop new macros and utilities
- Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance
- Complete job-required and project-specific training
- Comply with applicable Everest and trial Sponsor’s Policies, SOPs, and WIs
- Document data and programming information in accordance with corporate SOPs and guidelines
- Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines
Requirements
What you’ll need- A Master’s or Ph.D. degree in Statistics, Biostatistics, Epidemiology, and Computer Sciences, with at least four years’ experience in clinical trial statistical programming
- A Bachelor’s degree in the above fields with at least six years’ experience in clinical trial statistical programming
Benefits
Comp & perks- Flexible work arrangements
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical programmingSDTMADaMquality controldata validationCDISC standardsmacros developmentdata integrity checksprogramming utilitiesdefine.xml
Soft Skills
project managementproblem solvingcommunicationteam leadershipclient relationship managementattention to detailorganizational skillsefficiency improvementtrust buildingtraining
Certifications
Master’s degreePh.D. degree