What are the responsibilities and job description for the Senior Manager, Statistical Programming position at Celcuity?
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 will work as 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 modeling work.
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
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 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.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.
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 will work as 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 modeling work.
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.
- Minimum 5 to 10 years of industry experience (pharmaceuticals, biotechnology, or CRO) in developing or overseeing efficient development of submission ready programming code for clinical trials using the SAS-based Statistical Computing Environment.
- Strong CRO oversight experience
- Solid verbal and written communication skills.
- Demonstrated ability to speak up appropriately and ask necessary questions.
- Experienced hands-on skill in programming with SAS is required. Knowledge of additional programming languages is a plus.
- Good knowledge of statistics and oncology drug development process.
- Strong experience performing 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, associated metadata, and specifications.
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 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.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.
Salary : $150,000 - $170,000
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