Troubleshoot programming, validation, and submission-related issues and support the implementation of procedures across assigned areas.
Support inspection readiness activities and respond to programming-related inquiries during regulatory inspections.
Collaborate effectively across project programming teams and broader functions to achieve reporting and submission objectives.
You bring a diligent, problem-solving attitude and thrive in a fast-paced environment with multiple priorities.
This role requires
MS (or BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or a related discipline.
5+ years of programming experience with an MS degree or 6+ years with a BS degree, preferably processing clinical trial data within the biotechnology, pharmaceutical, or health-related industry.
Project and people management experience.
Proven experience supporting regulatory submissions and compliance with global standards, including CDISC, FDA, EMA, and PMDA requirements.
Proficient SAS programming skills in a clinical data environment, including Base SAS, SAS/STAT, Macro, and Graph.
Strong expertise in CDISC standards, including SDTM, ADaM, and Define-XML.
Proficiency with Pinnacle 21 (P21), including reviewing and troubleshooting validation reports and issues.
Familiarity with electronic Common Technical Document (eCTD) submission formats.
Knowledge of open-source programming languages such as R and Python is highly desirable.
SAS certification is a plus.
Excellent communication, interpersonal, collaboration, problem-solving, and organizational skills, with strong attention to detail and the ability to manage multiple priorities.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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. If you have any questions, please speak with your recruiter.
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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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.
