Senior Manager, Statistical Programming

Celcuity; United States; On-site; USD 160,000 - 185,000; Full time

Job summary

Celcuity is seeking a Manager, Statistical Programming to oversee programming activities from study planning through database lock, reporting, and regulatory submission. This role provides technical leadership and ensures timely, high-quality deliverables, collaborating with Biostatistics, Clinical Development, Data Management, Regulatory Affairs, Medical Writing, and CRO/vendor partners.

The position emphasizes leading SDTM/ADaM programming, creating reusable tools, and guiding a team in a

Qualifications

• 8+ years of statistical programming experience in pharma/biotech/CRO
• Strong SAS programming skills in a clinical trial setting
• Hands-on CDISC SDTM/ADaM experience
• Experience developing/validating TLFs, datasets and analysis outputs
• Regulatory submission support knowledge (FDA/EMA/PMDA) is a plus
• CRO/vendor oversight experience preferred
• Able to manage multiple priorities with attention to detail
• Excellent communication and collaboration in a remote/global environment

Responsibilities

• Leads and oversees statistical programming activities for assigned studies (SDTM/ADaM, TLFs)
• Develops and reviews SAS programs for study deliverables and reporting outputs
• Ensures deliverables meet timelines, quality, SOP, CDISC, and regulatory specs
• Supports regulatory submissions and related documentation
• Mentors and guides junior programmers and coordinates with CRO/vendor partners
• Coordinates with cross-functional teams to ensure study goals are met
• Identifies risks and drives continuous improvement in programming processes

Skills

Leadership

Statistical programming

Regulatory submission

SAS programming

CDISC SDTM/ADaM

Mentoring

Cross-functional collaboration

Tools

SAS Macros

Automation

Pinnacle 21

Job description

Celcuity is seeking a Manager, Statistical Programming to oversee programming activities from study planning through database lock, reporting, and regulatory submission. This role provides technical leadership and ensures timely, high-quality deliverables, collaborating with Biostatistics, Clinical Development, Data Management, Regulatory Affairs, Medical Writing, and CRO/vendor partners.

The position emphasizes leading SDTM/ADaM programming, creating reusable tools, and guiding a team in a