BioSpace
Website:
biospace.com
Job details:
About Regeneron
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.
As an Associate Director, Clinical Data Reporting, you will provide leadership and operational oversight for clinical and external data reporting across clinical development programs. You will drive the delivery of high-quality data programming outputs, reconciliation workflows, and reporting solutions that support clinical trial quality, compliance, and informed decision-making.
This position is office-based and will be on site at Regenerons Hyderabad office.
A Typical Day May Include The Following
- Leading program-level oversight for clinical data reporting and programming deliverables across development programs
- Driving development of participant-level listings, exception reports, external data reconciliation outputs, and operational metrics
- Establishing and maintaining reporting standards, templates, and scalable programming approaches
- Providing subject matter expertise in data programming, transformation, and visualization to enhance reporting capabilities
- Collaborating with cross-functional teams to align priorities and ensure timely delivery of reporting outputs
- Ensuring adherence to regulatory requirements, quality standards, and inspection readiness expectations
- Driving continuous improvement and automation of reporting workflows
- Identifying and managing risks related to data quality and delivery timelines
- Monitoring KPIs to assess reporting performance and enhance processes
- Leading and mentoring reporting and programming teams to drive operational excellence
This Job May Be For You If You Have
- Strong expertise in clinical data management, reporting, and data visualization
- Experience working with clinical trial data, including eCRF and external data sources such as PK, biomarker, imaging, and ECG
- Deep understanding of data transformation, validation, and reconciliation processes
- Strong knowledge of regulatory standards such as ICH-GCP, CDISC, and 21 CFR Part 11
- Experience with tools such as SAS, R, Tableau, Power BI, Spotfire, or similar reporting platforms
- Proven ability to work cross-functionally and manage stakeholder expectations
- Strong analytical, problem-solving, and communication skills
To Be Considered For This Role, You Must Have
- Bachelors degree with 10+ years of relevant experience
- 10+ years of experience in clinical data management or related areas within pharma/biotech
- At least 5+ years of leadership experience managing teams and mentoring staff
- Strong experience in clinical data reporting, programming, and analytics
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 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.
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