This is a Principal Statistical Programmer Analyst or Associate Manager level position for statistical programming. Key responsibilities and skills may include, but are not limited to:
- Programming edit checks for Data Management with SAS.
- Create tables, listings and figures for clinical study report.
- Annotated blank CRF (acrf.pdf) following FDA/CDISC or sponsor guidelines.
- Create or QC SDTM specifications and SDTM datasets.
- Create or QC ADaM specifications and ADaM datasets.
- Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf).
- Create define.xml or define.pdf following FDA/CDISC or sponsor guidelines.
- Serve as project lead or team lead for the programming group.
- Answer technical questions; Resolve or solve technical problems.
- Work with global team or sponsors to coordinate project deliverables, timelines and resources.
- For Programming Associate Manager, manage programming/project team; work with management team, take initiatives and follow through to develop the programming team.
- Be a role model for team members.
Qualifications
- Bachelor’s degree in computer science (CS), statistics or related scientific disciplines with 7 yrs. clinical programming experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming experience.
- Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
- Good understanding of clinical drug development process.
- Detail oriented.
- Strong communication skills and coordination skills.
- Can communicate with global team independently.
ClinChoice is an Equal Opportunity Employer / Committed to Diversity
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