Senior Statistical Programming Lead – SDTM/ADaM Equity

Celcuity Inc.; Minneapolis, Northern (MN, KY); Hybrid; USD 160,000 - 185,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) match

PTO and paid holidays

New hire equity package

Job summary

Celcuity Inc. is seeking a Manager, Statistical Programming to oversee programming activities from study planning to database lock and regulatory submission.

You will provide technical leadership, ensure timely, high-quality deliverables, and collaborate with Biostatistics, Clinical Development, Data Management, and CRO/vendor partners. The role emphasizes CDISC standards, SDTM/ADaM, and the development of reusable tools, with responsibility for mentoring staff and ensuring compliance across

Qualifications

• Eight (8) years of statistical programming experience in pharma, biotech, CRO, or healthcare.
• Strong SAS programming within a clinical trial environment.
• Strong CDISC standards knowledge (SDTM/ADaM).
• Experience with SDTM/ADaM datasets, TLFs, and regulatory submission support.
• Regulatory submission experience (FDA/EMA/PMDA) preferred.
• CRO/vendor oversight experience is a plus.
• Ability to manage multiple priorities with attention to detail and quality.
• Excellent verbal, written, and interpersonal communication in a global, remote environment.

Responsibilities

• Represent Statistical Programming in study team meetings and provide input from planning through database lock.
• Lead and oversee SAS programming for studies, including SDTM, ADaM, and TLFs.
• Develop, review, and validate datasets and outputs; ensure quality and timelines.
• Support regulatory submissions and related documentation; contribute to publications.

Skills

Leadership

Communication

Mentoring

Remote collaboration

Tools

SAS

CDISC (SDTM/ADaM)

Pinnacle 21

R/Python (preferred)

Job description

Celcuity Inc. is seeking a Manager, Statistical Programming to oversee programming activities from study planning to database lock and regulatory submission.

You will provide technical leadership, ensure timely, high-quality deliverables, and collaborate with Biostatistics, Clinical Development, Data Management, and CRO/vendor partners. The role emphasizes CDISC standards, SDTM/ADaM, and the development of reusable tools, with responsibility for mentoring staff and ensuring compliance across