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Manager, Statistical Programming
ClinChoiceManager of Statistical Programming for a global CRO overseeing clinical programming tasks independently. Leading programming activities for clinical studies with a focus on quality and efficiency.
About the role
Key responsibilities & impact- Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs for Clinical Study Report (CSR) if similar TFLs exist and from scratch for new outputs.
- Capacity for independent programming and review of reports and outputs.
- Customize outputs and graphics according to delivery specifications of target audience on the direction of biostatisticians.
- Responsible for supporting the Programming deliveries of a clinical study or project.
- Programs independently with high efficiency and quality.
- Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
- Ensures compliance with standards and automation usage.
- Plans and support team activities and tasks.
- Communicates and escalates risks within the assigned studies and/or projects.
Requirements
What you’ll need- Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 6 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 8 yrs. of clinical programming (CDISC) experience.
- Oncology/Hematology TA experience is required.
- ISS & ISE experience is required.
- Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
- Good understanding of the clinical drug development process.
- Strong communication skills and coordination skills.
- Current knowledge of technical and regulatory requirements relevant for the role.
- Ability to proactively manage concurrent activities within a project
Benefits
Comp & perks- 401(k) matching
- Professional development opportunities
- Supportive culture
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
SAS programmingclinical programmingCDISCTFLs developmentreport reviewoutput customizationautomationbest practices developmentclinical trial processregulatory compliance
Soft Skills
independent programmingcommunication skillscoordination skillsrisk escalationteam planningefficiency improvementquality assuranceproactive management