Manager Statistical Programming

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

Benefits offered by this job

Health and wellness programs

401(k) company match

Annual bonuses

Paid time off

Job summary

Regeneron in Cambridge, Massachusetts is seeking a Manager to lead programming efforts for clinical studies. This role involves managing all programming deliverables, ensuring quality support for analysis, and overseeing documentation in a regulated environment.

The ideal candidate will possess a Master’s degree, along with 8-10 years of relevant experience in the biotech or pharmaceutical industry, including programming expertise and project management skills.

Regeneron offers a competitive salary range of $128,600 to $210,000 annually, along with comprehensive benefits including health programs, 401(k) matching, and paid leave.

Qualifications

• 8-10 years of relevant work experience.
• 5+ years of programming experience in the biotech or pharmaceutical industry.
• Project and people management experience preferred.

Responsibilities

• Lead programming support for clinical studies.
• Oversee documentation and maintenance of programming code.
• Act as representative in multidisciplinary study teams.

Skills

Expertise in therapeutic areas or standard tools

SAS Programming

Team leadership

Data processing for clinical trials

Education

Master’s Degree in relevant field

Job description

Please note: This role is onsite only and is not eligible for remote work.

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. The incumbent oversees documentation and ensures consistent maintenance of code, logs, and output within a regulated environment. The incumbent also meets statistical ad hoc requests of senior management.

A Typical Day In This Role Looks Like

• 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 submission 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 performance and recommend yearly goals.
• Advise all direct reports about the procedures surrounding retention of data, records, and information for employees in their group.

In order to be considered qualified for this role

• 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 offers comprehensive benefits, including health and wellness programs, fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off and paid leaves such as military and parental leave.

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.