Senior Data Standards Analyst
Hyderabad, India Permanent Posted on Dec. 30, 2024 Closing on Feb. 27, 2025Job title: Senior Data Standards Analyst
Location:IN / Hyderabad
Grade: L2-1
About the job
As a member of a CIG (Clinical Information Governance) team, the Sr. Data Standards Analyst acts as a metadata expert as he/she provides in-depth knowledge and guidance on clinical data standards (CDISC) and best practices for metadata management across global and study-specific levels. Understand the CDISC models (CDASH, SDTM, External Data, Controlled Terminology) and all regulatory requirements regarding Data Standards.
Actively leads the governance of one of the CDISC Data Standards models (CDASH, SDTM, External Data or Controlled Terminology) across Therapeutic Areas. The Sr. Data Standards Analyst will bridge the gaps between global metadata strategy and its adoption within therapeutic area studies.
The Sr. Data Standards Analyst represents Sanofi in all internal & external networks initiatives (CDISC, TransCelerate, etc.), monitor actively Health Authorities requirements, and promotes Data Standards knowledge and best practices within Sanofi.
At the study level, the Sr. Data Standards Analyst supports clinical teams serving as a Subject Matter Expert (SME) during the review of study-specific metadata based on customer needs and provides effective solutions through regular analysis of information reported from a broad variety of sources.
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Clinical Information Governance team as Sr. Data Standards Analyst and you’ll help shape the future of Clinical Data Standards at Sanofi and across our industry.
Main responsibilities:
Acts as a Metadata Lead Expert for CDASH, SDTM, External Data or Controlled Terminology.
Understands the application of the CDISC models across the life cycle of a trial.
Leads Global/Study Request Review Meetings for the specific Data Standards Model of expertise.
Provides SME expertise during the eCRF review (study level) with the Study Team and ensures study-specific metadata are aligned with the CIG Clinical Data Standards strategy.
Review of study requests (Data Collection, External Data, Controlled Terminology or SDTM).
Contributes to develop CDISC-compliant end-to-end metadata specifications for new study-specific forms.
Support other Clinical Data Standard Leaders with the management of global requests (review/meeting/implementation in Sanofi Metadata/metadata QC/standard documentation updates).
Participate in Core and TA standard needs definition (SDTM and TA WG)
Contribute to Global governance process definition and/or optimization.
Monitor study-specific forms developed with Standard potential at the Therapeutic Area level.
About you
Experience:Experience in Pharmaceutical Industry, with strong involvement in the “clinical data flow”, specialized in Data Standards Management.
• Strong knowledge of industry data standards and practices (e.g., CDISC/CDASH/SDTM). Having strong level of CDISC skills and Metadata Governance practices. (Preferred CDISC certification in one of more of the models).
Good understanding of end-to-end clinical data flows and data structures.
Soft and technical skills:Strong English skills (verbal and written), ability to exchange fluently in a global environment.
Efficient communication skills and good organization skills.
Ability to negotiate and gain acceptance of others.
Ability to coordinate/oversee multiple tasks simultaneously.
Project team collaboration by interacting with internal or external partners in/outside the Department and with their leaders.
Self-motivated & results driven with attention to detail and quality.
Education: Bachelor’s degree or above, preferably in Life Science or related field
Languages: Excellent English language knowledge – written and spoken.
Pursue progress. Discover extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
You have not viewed any jobs yet.
You have not saved any jobs yet.
Hubs
From Bogota to Budapest, Kuala Lumpur to Hyderabad – it’s your skills that help the Sanofi world go round. With a role in one of our Hubs, you’re right at the heart of our global transformation, as we fearlessly work together to cut the time it gets new treatments to patients. By making the most of your creativity and bringing your unique self you’re supportingyou’ll help others to perform at their best. Let’s make the discoveries that’ll change lives.
Find out more about this location
Experience possibility
-
-
Cambridge Crossing
We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.
-
Innovation in Action
Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.
-
Sustainable and Green
Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.
-
Sanofi’s AI Centre of Excellence in Toronto
The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.
-
Ama
Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.
-
Sanofi Canada's Philanthropic Efforts
By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.
-
Emmanuel
Emmanuel, Head of the Sanofi Digital Accelerator, shares how his team builds digital solutions that enable patients to receive new treatments to help improve their lives.
-
Dimitrije
Dimitrije shares insights into the work carried out by the AI Centre of Excellence in Toronto.
-
Ziv
Read Ziv's first-hand account describing the reasons he chose to join Sanofi – and many of the reasons why he now chooses to stay.
-
When you grow, we all grow
We strive to support your whole self with thoughtfully crafted rewards that benefit you physically, financially, mentally and socially. Whatever your role, you'll thrive in our inclusive teams.
-
Build a career with purpose
Bring your passion to your role and impact millions of people around the world. You're in the driver's seat – just set your goals, and we'll provide the training and support that will get you there.
-
Bolder, better futures
Change your life. And the lives of millions around the globe. How? By starting a career where you're supported to grow, while having a tangible impact and learning from the best.
-
Our locations
We're in 60+ countries, all pulling together to define the future of healthcare. Wherever you work, you'll develop your career alongside experts, using technology to chase bigger breakthroughs.
-
Sanofi Stories
At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.
-
Sanofi at Cambridge Crossing
Dubbed Sanofi at Cambridge Crossing, our new state-of-the-art facility will create an innovation hub promoting close collaboration and integration among business units. Join us and become part of a team dedicated to chasing the miracles of science that improve people’s lives.
-
Why Sanofi
Get access to the tools, training, and support to reach your goals. By fulfilling your potential, you’ll help us achieve our aim of halving the time from discovery to therapy.
-
Our people & culture
We're the first in Pharma to have a DE&I board. We also have Employee Resource Groups that create spaces for every Sanofian to be heard. Your voice matters – use it to shape our future.
-
Sanofi's Postdoctoral Program
Designed for high-caliber Ph.D. graduates, Sanofi's Postdoctoral Program helps you advance your scientific career in a state-of-the-art environment.
-
Physician Careers at Sanofi
At Sanofi, physicians like you have the opportunity to collaborate on new ideas and challenge established thinking. Learn about Physician careers here.
-
AI Centre of Excellence
The AI Centre of Excellence at Sanofi is a unique data-driven team based in Downtown Toronto. We pride ourselves on being data-obsessed and highly focused on using state-of-the-art technologies to drive global impact.
-
Join our
talent community
What could we achieve together? Every Sanofian works on projects that truly make a difference to people’s lives.
Sign up today and discover our latest opportunities as soon as they’re available.