Dmds-0, Data Standards Expert - Bengaluru, Karnataka, India - Merck KGaA

Merck KGaA

Verified Company

Bengaluru, Karnataka, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans '" so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics.

Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.

Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life.

Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

We are currently seeking a highly skilled and detail-oriented Data Standards Expert (SDTM Expert) to join our team.

As a Data Standards Expert, you will play a crucial role in ensuring regulatory compliance for data submission through your expertise in SDTM standards and validation.

Your responsibilities will include reviewing SDTM packages, creating SDTM study metadata, coordinating tasks with external partners, and overseeing SDTM programming, coordinating tasks between CROs and internal teams.

Collaborates with stakeholders to optimize data standards and processes. Updates and maintains the SDTM library. Develops and maintains validation and quality checks tool for SDTM standard and packages. Provides guidance on changes to clinical data standards. Participates in publication and communication activities. Supports CRO surveillance and contributes to continuous improvement projects. Interfaces with external vendors and partners to ensure adherence to the highest standards of data quality and compliance.

Qualifications:

Advanced degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals), Mathematics or Computer Sciences or equivalent industry experience
Proven experience in the pharmaceutical/biotechnology industry, minimum of 10 years
Proven experience in Data Standards Development and Governance
Expertise in SDTM standard
Proficiency in data management
SAS programming Experience >7 years Project leadership expertise

What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.

We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology.

We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress