Manager, Statistical Programming (remote)
ClinChoice
•Remote
About The Position
ClinChoice is searching for a Manager, Statistical Programmer to join one of our clients remotely. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Requirements
- Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 6 yrs. of clinical programming (CDISC) experience; OR 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.
Responsibilities
- Lead and support all programming activities per the project strategies.
- Independently implement and drive programming to support ongoing clinical studies and requests for study report and regulatory submission.
- 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.
- Independently program and review reports and outputs.
- Customize outputs and graphics according to delivery specifications of target audience on the direction of biostatisticians.
- Support the Programming deliveries of a clinical study or project.
- Program independently with high efficiency and quality.
- Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
- Ensure compliance with standards and automation usage.
- Plan and support team activities and tasks.
- Communicate and escalate risks within the assigned studies and/or projects.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
