Senior Manager, Data Management - Reports Development
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
In this role a typical day may include the following:
Support the design, development and implementation of clinical reports and dashboards to enable the Global Development group to best meet the quality and processing needs, including CRO oversight, of the clinical trial data (from EDC and other external sources). Contribute to the data review strategy and drive the selection of reports tools/platform. Facilitates the creation of study-specific data review reports specifications and aggregating data review reports to establish a reports library for use across studies. May support related cross-functional data review needs and tools for clinical study teams.
- Supply the development of the Data Management data review strategy and reports platform selection/implementation
- Translate clinical study teams needs into specifications and provide custom data review reports solutions
- Provide technical project management, report specifications development, deployment timelines for study-level and standard library-level reports
- Stay current on new product releases and recommend appropriate adoption to the users
- Collaborate with training team to deliver custom role based training
- Maintain the platform and trouble-shoot errors
- Contribute reports to support the Sponsor oversight to CROs and other data providers by developing targeted reports
- Build and maintain data review reports for all clinical data, to include integrated data, CRF data, eCOA and biomarker data.
- Liason with Medidata Rave to address special needs on reports
- Coordinate with Medical Monitoring Team and Data Analytics Team to meet business needs
- Align with the Data Governance Team to ensure data reports meet specification requirements
This role might be for you if:
You have a BS in Computer Science, Engineering, Life Sciences or equivalent,. You have 5 or more years of experience in biotechnology, pharmaceutical or CRO settings and at least You have 3 or more years in reports development. Additionally, previous RAVE EDC experience a plus
- Strong experience in report development using main-stream report technologies like JReview, WebIntelligence, Buisness Objects 4, Spotfire, Oracle BI, or Crystal Reports.
- Experience with EDC and clinical data management systems: Medidata Rave is preferred.
- Experience in technical writing.
- Proficiency in SQL and scripting with advanced queries, stored procedures and views. SAS, R or Python programming is a plus.
- Experience in developing the tools/reports to support CRO oversight activities
- Understanding of statistical outputs (tables, listings and graphs) to ensure data review reports match asset needs
- Solid grasp of clinical trial data management concepts and challenges of data managers
- Detail oriented, ability to multi-task with strong prioritization, planning and organization skills
- Ability to analyze customer requirements and implement best fit solutions
- Good communication, work ethics and problem solving skills
- May supervise contractor report developers and/or DM FSP resources
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.