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The Standard of Excellence
Manager, Statistical Programming
Location
United States
Posted
7 days ago
Salary
0
Seniority
Senior
Job Description
Manager, Statistical Programming
ClinChoice
• 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.
Job Requirements
- 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
- 401(k) matching
- Professional development opportunities
- Supportive culture
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