Manager Statistical Programming

Regeneron Pharmaceuticals; Cambridge (MA); On-site; USD 128,600 - 210,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Manager to provide timely programming support for clinical study data and lead the programming workstream from study inception through regulatory submission and product launch. This onsite role emphasizes leadership of the programming team, adherence to internal standards, and collaboration with CROs to ensure quality deliverables.

Responsibilities include overseeing SDTM/ADaM development, managing e submissions, and guiding junior staff while maintaining

Qualifications

• Master’s degree required.
• 8–10 years of relevant work experience, or 5+ years with a Master’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline.

Responsibilities

• Lead the programming aspect of a project for all programming deliverables from study through regulatory approval, product launch, data monitoring boards and annual reports.
• Oversee documentation and ensure maintained code, logs, and output within a regulated environment.
• Act as programming representative to the study team to ensure timely, quality analysis and reporting of clinical trials up to regulatory approval.
• If applicable, lead an application development and act as the programming representative to the user audience.
• Determine resource requirements for the department’s therapeutic area or function.
• Review resumes, screen and interview candidates for contractor and permanent positions.
• Provide feedback to management on team performance and set yearly goals.

Skills

SAS Certification

Project management

People management

Education

Master’s Degree

Job description

***Please note this is an onsite role and NOT eligible remote.

A Manager provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study team, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan, programming specification or user requirements document using internal standards and guidelines. The incumbent provides guidance in implementing and executing the programming and project standards. The incumbent will be responsible for leading the programming aspect of a project, both internally or CROs, for all programming deliverables from the single study through to regulatory approval, product launch, data monitoring boards and annual reports. Oversees documentation and ensures consistent maintenance of code, logs, and output within a regulated environment. Meets statistical ad hoc requests of senior management.

Typical Day

• Develop an expertise within a therapeutic area or standard tool. Work with minimal supervision to perform, coordinate and oversee the preparation, execution, reporting and documentation of a project
• Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements utilizing Regeneron tools and methodologies and current industry standards (i.e. CDISC SDTM / ADaM)
• Manage the effort, including e submissions deliverables, using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables. Provide programming support for complex presentations and more complex statistical ad-hoc requests.
• Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports.
• If applicable, lead an application development and act as the programming representative to the user audience.
• Work with management to determine resource requirements for therapeutic area or department function responsibilities.
• Review and select resumes, screen and interview candidates for contractor and permanent positions.
• Provide feedback to management regarding team member’s contributions to the work effort for evaluating individual's performance and recommend yearly goals.
• Advise all direct reports about the procedures surrounding retention of data, records, and information for employees in their group.

Qualifications

• Master’s Degree
• 8-10 years of relevant work experience
• SAS Certification desirable.
• Also acceptable - 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry, including some project and people management experience with a Master’s Degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline.

Salary Range (annually)

$128,600.00 - $210,000.00

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.