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Reporting to the Director, Statistical Programming, the Manager, Statistical Programming is responsible for overseeing statistical programming activities for the assigned projects from study planning through database lock, reporting, and regulatory submission. This person provides technical leadership and statistical programming expertise to ensure timely, high-quality, and compliant delivery of clinical trial programming deliverables. The Manager, Statistical Programming is a department-level contributor who collaborates closely with Biostatistics, Clinical Development, Data Management, Regulatory Affairs, Medical Writing, and CRO/vendor partners. The core duties and responsibilities of the Manager, Statistical Programming are delineated below.

Responsibilities:

Department Level

• Contributes to the development, review, and implementation of departmental SOPs, programming standards, templates, and processes.
• Supports continuous improvement initiatives to enhance programming quality, efficiency, standardization, and compliance.
• Contributes to the development and maintenance of reusable programming tools, macros, and automation solutions.
• Supports resource planning and prioritization across assigned studies and programming activities.
• Provides technical guidance, mentoring, and knowledge sharing to statistical programmers.
• Participates in departmental and cross-functional initiatives as appropriate.
• Contributes to inspection readiness activities and supports departmental responses to programming-related questions or requests

Statistical Programming/Study Tasks

• Represents Statistical Programming in study team meetings and provides programming input throughout the clinical development lifecycle.
• Leads and oversees statistical programming activities for assigned clinical studies, including SDTM, ADaM, and Tables, Listings, and Figures (TLFs).
• Develops, reviews, and/or oversees SAS programs for clinical study deliverables, analysis datasets, and reporting outputs.
• Reviews and provides input on programming specifications, dataset documentation, validation results, and final deliverables.
• Ensures statistical programming deliverables are completed according to timelines, quality standards, SOPs, CDISC standards, and regulatory requirements.
• Supports regulatory submission activities, including preparation and review of SDTM/ADaM datasets, Define-XML, annotated CRF, cSDRG, ADRG, and related submission documentation.
• Supports clinical publications, abstracts, posters, manuscripts, and external scientific communications through programming deliverables, analysis datasets, tables, listings, and figures.
• Supports ad hoc analyses, exploratory analyses, and data requests to address clinical development, safety, and business needs.
• Supports real-world evidence (RWE) initiatives through programming, data preparation, analysis dataset development, and reporting using real-world data sources where applicable.
• Coordinates and supervise programming activities with CROs and external service providers to ensure quality, consistency, and timely delivery of assigned programming activities.
• Monitors progress of programming activities and proactively identifies risks, issues, and opportunities for mitigation.
• Reviews clinical data outputs and programming results to ensure accuracy, completeness, and compliance with specifications.
• Provides technical support and guidance to resolve complex programming issues.
• Works independently and collaboratively toward assigned study goals and departmental objectives.

Qualifications:

• 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.
• CRO/vendor oversight experience preferred.
• 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.
• 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.

About Us:

Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway.  REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.

The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $160,000 - $185,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

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