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Senior Manager/Associate Director, Statistical Programming

CelcuityRemote
Remote Full-time $184K/yr - $200K/yr

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Experience Level

Senior Level Manager

Qualifications

Responsibilities: Represent the statistical programming function in multi-disciplinary team meetings. Proactively gather necessary specification details for deliverables. Review and approve Statistical Analysis Plans (SAPs) and TFL shells prior to programming output initiation. Contribute insights on key study-related documents generated by other functions or external data sources. Create or review and approve CDISC-compliant datasets and associated documentation for electronic submissions.

About the job

Position Summary:

Join our dynamic team as a Senior Manager/Associate Director in Statistical Programming at Celcuity. In this pivotal role, you will report directly to the Director of Statistical Programming, providing essential technical expertise and oversight for programming delivered by our CRO partners. You will play a crucial role in developing statistical programming deliverables that facilitate the thorough analysis and reporting of clinical study data, all in adherence to departmental SOPs and regulatory guidelines.

As a Senior Manager/Associate Director, you will collaborate within a multidisciplinary team, lending your programming expertise to clinical trials. You will coordinate and execute the preparation, execution, reporting, and documentation of statistical programming activities both internally and externally with CROs. Your advanced programming skills will be vital in creating datasets and analytical displays for study monitoring, clinical study reports, and exploratory analyses, including support for biomarker studies, publications, and modeling work.

The ideal candidate will design and develop SAS programs tailored to execute statistical analyses and clinical trial reporting deliverables, including tables, listings, and graphs for clinical study reports, as well as interim analyses and submission-ready data, aligning with our clinical strategies. You will also conduct quality control and validation of clinical trial outputs, ensuring compliance with industry and regulatory standards while maintaining comprehensive statistical programming documentation.

This role necessitates establishing strong collaborative relationships with internal and external stakeholders, including programmers, data managers, statisticians, analysts, and clinical staff, to ensure the delivery of high-quality clinical data that supports timely and accurate statistical analysis and reporting.

About Celcuity

Celcuity is committed to advancing the field of precision medicine through innovative approaches to cancer treatment. Our focus on collaboration and excellence drives our mission to deliver high-quality data and insights that improve patient outcomes.

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