Senior Manager, Statistical Programming

Job Description

Job Description

Salary : $150,000-$170,000 DOE

Title : Senior Manager, Statistical Programming

Location : Remote

Position Summary :

We are seeking a Senior Manager, Statistical Programming, who will report into the Director, Statistical Programming. You will be responsible for providing technical expertise, and oversight of programming by CRO partners for the analysis and reporting of clinical study data in accordance with departmental SOPs and regulatory guidelines. This role is also responsible for hands-on generation of analysis results for rapid responses, ad hoc analyses, exploration of biomarkers, etc.

The Senior Manager of Statistical Programming willworkas part of a multidisciplinary team, providing programming support for clinical trials. The Statistical Programmer will execute on the preparation, production, validation, reporting, and documentation of statistical programming activities internally and externally (CRO). They will demonstrate state-of-the-art programming knowledge / skills, develop datasets and analysis result displays for study monitoring and clinical study reports and develop analysis datasets to support exploratory analyses and data analytics for biomarkers, publications, and / or modelingwork.

The successful candidate will effectively design and develop SAS programs to execute statistical analysis and produce clinical trial reporting deliverables, including tables, listings, graphs for clinical study reports, displays for publications, interim and / or ad hoc analysis, and submission-ready data in alignment with assigned clinical plans and strategies. This role will develop and perform appropriate quality control and validation of output in support of assigned clinical studies, while creating and maintaining statistical programming documentation including programming specifications as appropriate and in alignment with industry and regulatory standards.

This role will also support database programming activities providing data listings, TFLs, and other results for medical data review and monitoring, metrics generation, etc.

Responsibilities :

• Aggressively seek out needed specification details for the deliverables.
• Perform quality control of datasets (ADaM, SDTM, SEND) based on CDISC dataset specifications, standard and custom data tables, listings, and graphs, as well as derived datasets and specifications.
• Ensure the quality of tables, figures, and listings (TFLs) on time for electronic submission to regulatory agencies.
• Develop SAS validation procedures and test plans, as necessary.

Qualifications :

About Us :

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.

Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K / AKT / mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+ / HER2- ABC in the 1L and 2L settings. A Phase 1b / 2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going.

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 $150,000-$170,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidates 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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We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

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