Celcuity
Senior Manager, Statistical Programming
Celcuity, Minneapolis, Minnesota, United States, 55400
Title
Senior Manager, Statistical Programming
Location
Remote
Position Summary
We are seeking a Senior Manager, Statistical Programming, who will report to the Director, Statistical Programming. The role involves 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. It also includes hands‑on generation of analysis results for rapid responses, ad‑hoc analyses, and biomarker exploration. The Senior Manager will work within a multidisciplinary team, providing programming support for clinical trials. Responsibilities include preparation, production, validation, reporting, and documentation of statistical programming activities both internally and with CROs. The role requires state‑of‑the‑art programming knowledge, development of datasets and analysis result displays for study monitoring and reports, and support for exploratory analyses and data analytics for biomarkers, publications, and modeling work. Key duties include designing and developing SAS programs for statistical analysis and producing clinical trial reporting deliverables such as tables, listings, graphs, and submission‑ready data. This position will develop and perform quality control and validation of outputs, maintain programming documentation, and support database programming activities for data listings, TFLs, and medical data reviews.
Responsibilities
Aggressively seek out needed specification details for deliverables.
Perform quality control of datasets (ADaM, SDTM, SEND) based on CDISC specifications, standard and custom tables, listings, and graphs.
Ensure tables, figures, and listings (TFLs) are completed on time for electronic regulatory submission.
Develop SAS validation procedures and test plans as needed.
Qualifications
Minimum 5–10 years of industry experience (pharmaceuticals, biotechnology, or CRO) in developing or overseeing efficient, submission‑ready programming code using SAS.
Strong CRO oversight experience.
Solid verbal and written communication skills.
Demonstrated ability to speak up appropriately and ask necessary questions.
Hands‑on SAS programming skills required; knowledge of additional programming languages is a plus.
Good knowledge of statistics and the oncology drug development process.
Extensive experience performing quality control of datasets based on CDISC specifications, including metadata and derived datasets.
About Us Celcuity is a clinical‑stage, publicly traded biotechnology company dedicated to extending the lives of cancer patients by developing targeted therapies for multiple solid tumor indications. The company focuses on cellular drivers of tumor growth and is developing the PI3K/AKT/mTOR pathway inhibitor gedatolisib, among other candidates.
Compensation & Benefits Base pay range: $150,000–$170,000 DOE (dependent on geography, qualifications, skills, and experience). The successful candidate will be eligible for an annual performance incentive bonus, an equity package, and comprehensive benefits including medical, dental, vision, 401(k) match, PTO, and paid holidays.
Legal & EEO Statement Celcuity is an Equal‑Opportunity Employer. Celcuity is committed to fair and equitable compensation practices and strives to provide employees with competitive total compensation packages.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Design, Art/Creative, and Information Technology; Biotechnology
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Senior Manager, Statistical Programming
Location
Remote
Position Summary
We are seeking a Senior Manager, Statistical Programming, who will report to the Director, Statistical Programming. The role involves 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. It also includes hands‑on generation of analysis results for rapid responses, ad‑hoc analyses, and biomarker exploration. The Senior Manager will work within a multidisciplinary team, providing programming support for clinical trials. Responsibilities include preparation, production, validation, reporting, and documentation of statistical programming activities both internally and with CROs. The role requires state‑of‑the‑art programming knowledge, development of datasets and analysis result displays for study monitoring and reports, and support for exploratory analyses and data analytics for biomarkers, publications, and modeling work. Key duties include designing and developing SAS programs for statistical analysis and producing clinical trial reporting deliverables such as tables, listings, graphs, and submission‑ready data. This position will develop and perform quality control and validation of outputs, maintain programming documentation, and support database programming activities for data listings, TFLs, and medical data reviews.
Responsibilities
Aggressively seek out needed specification details for deliverables.
Perform quality control of datasets (ADaM, SDTM, SEND) based on CDISC specifications, standard and custom tables, listings, and graphs.
Ensure tables, figures, and listings (TFLs) are completed on time for electronic regulatory submission.
Develop SAS validation procedures and test plans as needed.
Qualifications
Minimum 5–10 years of industry experience (pharmaceuticals, biotechnology, or CRO) in developing or overseeing efficient, submission‑ready programming code using SAS.
Strong CRO oversight experience.
Solid verbal and written communication skills.
Demonstrated ability to speak up appropriately and ask necessary questions.
Hands‑on SAS programming skills required; knowledge of additional programming languages is a plus.
Good knowledge of statistics and the oncology drug development process.
Extensive experience performing quality control of datasets based on CDISC specifications, including metadata and derived datasets.
About Us Celcuity is a clinical‑stage, publicly traded biotechnology company dedicated to extending the lives of cancer patients by developing targeted therapies for multiple solid tumor indications. The company focuses on cellular drivers of tumor growth and is developing the PI3K/AKT/mTOR pathway inhibitor gedatolisib, among other candidates.
Compensation & Benefits Base pay range: $150,000–$170,000 DOE (dependent on geography, qualifications, skills, and experience). The successful candidate will be eligible for an annual performance incentive bonus, an equity package, and comprehensive benefits including medical, dental, vision, 401(k) match, PTO, and paid holidays.
Legal & EEO Statement Celcuity is an Equal‑Opportunity Employer. Celcuity is committed to fair and equitable compensation practices and strives to provide employees with competitive total compensation packages.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Design, Art/Creative, and Information Technology; Biotechnology
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