Sr Mgr Data Management

The Senior Manager of Data Management, External Data Services & Reports Development will be responsible for providing oversight of External Data Service Manager (s) on assigned clinical data management projects in multiple therapeutic areas. You will support the acquisition and delivery of high-quality external data that meet Regeneron standards and within timelines. External data includes, but is not limited to, data from Biomarkers, Wearable Devices, IRT, Imaging and Electronic Clinical Outcomes Assessment (eCOA).

In this role, a typical day might include the following:

• Serves as the primary DM contact to interact with external vendors and key Regeneron customers for overall project planning and issue resolution within External Data Services and Report Development.
• Supervise staff in the development of Data Transfer Specifications (DTS) for assigned studies to ensure compatibility with SDTM/clinical database requirements. This will include: Standard programs for patient profiles, External Data Reconciliation programs, Standard and ad-hoc reports for data review using JReview & SAS
• Develop custom role-based training in collaboration with the Global Development Learning Center of Excellence. Establish goals, expectations, and accountabilities for staff.
• Coordinate with the Director of Data Management Central Services in the development of SOPs, Working Practice, Data Management Manual, and other data management standards.

This role may be for you if:

• You have end to end knowledge of drug development process
• Understanding of FDA/ICH guidelines for clinical study data
• Strong knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials
• Strong analytical and problem-solving skills.
• Knowledge of SQL and scripting with experience in developing advanced queries, stored procedures, and views. JReview, Spotfire and SAS programming is a plus.
• Solid understanding of CDISC and other industry standards guidelines
• EDC build (Rave) experience is a plus

To be considered: B.S degree – Major/ Minor (Biology, Computer Science, programming, data management, scientific or analytic subject area or equivalent) with experience with programming and strong knowledge of database structures. At least 8 or more years of clinical data management experience in a biotech, pharmaceutical or health related industry, managing and coordinating external data. At least 3 or more years of report development experience in a biotech, pharmaceutical or health related industry, managing and coordinating the development of clinical data reports. At least 5 or more years of various reporting and analytic tools – JReview, Spotfire, Qlik, SAS, and SQL.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$126,600.00 - $206,600.00