Manager Statistical Programming

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

Job summary

Regeneron is seeking a Manager-level Programmer to provide timely support for the study team on all programming matters, leading programming deliverables from data processing to regulatory submission. This onsite role in Cambridge involves overseeing code, logs, and outputs in a regulated environment and guiding adherance to internal standards.

The candidate should have a Masters degree with 8–10 years of relevant experience, SAS certification desirability, and demonstrated project and people

Qualifications

• Masters degree and 8–10 years of relevant experience in programming clinical data.
• SAS certification desirable; strong leadership and project management.
• Experience with processing clinical trial data in biotech/pharma sectors.

Responsibilities

• Lead programming efforts for studies from data processing to regulatory deliverables.
• Oversee documentation and maintain code, logs, and outputs in regulated environments.
• Coordinate with internal teams and CROs for analysis deliverables.
• Provide guidance on programming standards and project strategies.

Skills

Project leadership

Lead programmer

CDISC SDTM/ADaM

SAS

Data analysis

Education

Masters 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.

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

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 esubmssion 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 members contributions to the work effort for evaluating individual's performance and recommend yearly goals.
• Advises 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

• Masters 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 Masters Degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline.

Salary Range (annually)

$128,600.00 - $210,000.00