Principal Statistical Programmer
Tasks
- Develop and maintain programming utilities macros and best practices
- Document and archive programming and clinical trial data per SOPs
- Generate definexml files and statistical outputs for CSRs ISS and ISE
- Lead complex statistical programming projects
- Mentor train and provide technical guidance to junior programmers and biostatisticians
- Oversee SDTM and ADaM dataset development and validation
- Perform and review quality control checks
- Represent team in client interactions and project discussions
- Resolve CDISC compliance validation issues
- Support regulatory submission preparation review and quality assessment
Perks/Benefits
- Dental insurance
- Employee Assistance Program (EAP)
- Fitness reimbursement
- Home based office setup
- Life and AD D Insurance
- Long-term disability
- Medical insurance
- Paid time off
- Pension plan
- Performance bonus
- Remote work
- Short-term disability
- Sick leave
- Tuition reimbursement
- Vision insurance
Skills/Tech-stack
ADaM | Analysis Plan | CDISC | Clinical Trial Data | Clinical Trial Design | Clinical trial | DefineXML | Pinnacle 21 | Quality Control | Regulatory Submissions | SAS | SDTM | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Trial data | Trial design | Validation
Education
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