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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.
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
SAS programmingclinical programmingCDISCTFLs developmentreport reviewoutput customizationautomationbest practices developmentclinical trial processregulatory compliance
Soft Skills
independent programmingcommunication skillscoordination skillsrisk escalationteam planningefficiency improvementquality assuranceproactive management
Industry Keywords
Bachelor’s degreeMaster’s degreeOncologyHematologyISSISEICHGood Clinical Practicesclinical researchclinical drug development
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