Manager, Statistical Programming

Job not on LinkedIn

🕒 August 31

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $160k - $185k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

👻 Ghost score 3%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 Description

• Oversee statistical programming activities for assigned projects from study planning through database lock, reporting, and regulatory submission • Provide technical leadership and statistical programming expertise for timely, high-quality, compliant clinical trial programming deliverables • Contribute to departmental SOPs, programming standards, templates, processes, and continuous improvement initiatives • Develop and maintain reusable programming tools, macros, and automation solutions • Support resource planning and prioritization across assigned studies • Provide technical guidance, mentoring, and knowledge sharing to statistical programmers • Represent Statistical Programming in study team meetings throughout the clinical development lifecycle • Lead and oversee programming for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) • Develop, review, and oversee SAS programs for clinical study deliverables, analysis datasets, and reporting outputs • Review programming specifications, dataset documentation, validation results, and final deliverables • Support regulatory submissions, including SDTM/ADaM datasets, Define-XML, annotated CRF, cSDRG, ADRG, and related documentation • Support clinical publications, abstracts, posters, manuscripts, and external scientific communications • Support ad hoc and exploratory analyses, data requests, and real-world evidence initiatives • Coordinate and supervise CRO and external service-provider programming activities • Monitor progress and identify risks, issues, and mitigation opportunities • Review clinical data outputs and programming results for accuracy, completeness, and compliance • Provide technical support to resolve complex programming issues • Collaborate with Biostatistics, Clinical Development, Data Management, Regulatory Affairs, Medical Writing, and CRO/vendor partners

🎯 Requirements

• Minimum of eight (8) years of statistical programming experience within the pharmaceutical, biotechnology, CRO, or healthcare industry • Strong proficiency in SAS programming within clinical trial environment • Strong knowledge and practical experience with CDISC standards, including SDTM and ADaM • Experience developing, reviewing, and validating clinical trial datasets and Tables, Listings, and Figures (TLFs) • Experience supporting clinical studies from study start-up through database lock, reporting, and regulatory submission • Knowledge of regulatory submission requirements and experience supporting submissions to health authorities such as FDA, EMA, or PMDA • Experience with clinical trial programming documentation, validation processes, and quality control practices • Demonstrated ability to manage multiple priorities while maintaining strong attention to detail and quality • Excellent verbal, written, and interpersonal skills, with the ability to communicate effectively and collaborate with cross-functional teams in a remote/global environment • CRO/vendor oversight experience preferred • Experience with Pinnacle 21 or similar CDISC validation tools preferred • Experience with SAS macros, automation, and programming efficiency initiatives preferred • Experience with R, Python, or other programming technologies preferred

🏖️ Benefits

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays