Clinical data Standards SME

Biorce; Austin (TX); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

MacBook provided

Hybrid work model

Comprehensive health insurance

Pet-friendly office

Job summary

Biorce in Austin, TX is seeking a CDISC & Clinical Data Standards SME to drive the Data function from our U.S. hub. You will ensure every dataset mapped to SDTM/ADaM is submission-ready from day one and design standards into data pipelines.

Candidates bring 5+ years as a dedicated CDISC/SDTM/ADaM specialist, deep knowledge of implementation guides, and demonstrated ability to deliver regulatory-ready data. The role offers a hybrid work model, competitive compensation, and comprehensive benefits.

Qualifications

• 5+ years as a dedicated CDISC/SDTM/ADaM specialist (standards programming, mapping, or governance)
• Deep, hands-on knowledge of SDTM and ADaM implementation guides
• Experience ensuring submission-readiness for regulatory-facing clinical data
• Excellent attention to detail and documentation discipline
• Excellent written and verbal communication skills in English

Responsibilities

• Own SDTM and ADaM mapping specifications for data flowing through Aika
• Define and maintain clinical data standards governance across the data team
• Review and validate that data structures are submission-ready and audit-defensible
• Partner with Data Engineering and Architecture to embed standards into pipelines by design
• Stay current on CDISC updates and regulatory expectations (FDA/EMA)
• Train and support other team members on standards application

Skills

Attention to detail

English communication

Regulatory submission readiness

Education

CDISC certification (optional)

Tools

CDISC

SDTM

ADaM

Job description

About the company

Biorce is a pioneering Healthtech company dedicated to revolutionizing drug development through the power of AI. We are passionate about accelerating medical advancements and improving patient outcomes.

Our team comprises seasoned clinical research professionals, data scientists, and AI experts, working collaboratively to bridge the gap between cutting-edge technology and real-world clinical needs.

With an unwavering commitment to revolutionize healthcare, we envision a world where all patients benefit from accelerated and cost-effective access to treatments. Biorce is poised to redefine the landscape of healthcare, shaping a future where innovation and accessibility converge for the betterment of humanity.

About the role

Following our successful expansion into the U.S. and continued growth across Europe, we are seeking a CDISC & Clinical Data Standards SME to help drive our Data function from our Austin hub. This person will play a critical role in making sure every dataset Aika touches is mapped correctly to industry-standard formats, so outputs are trustworthy and submission-ready from day one.

Who We're Looking For:

A true standards specialist - someone whose career has been built around SDTM/ADaM mapping and clinical data standards governance, not just someone who's touched them occasionally. This person should be able to make Biorce's data submission-ready by design, not by clean-up.

Key Responsibilities:

• Own SDTM and ADaM mapping specifications for data flowing through Aika


• Define and maintain clinical data standards governance across the data team


• Review and validate that data structures are submission-ready and audit-defensible


• Partner with Data Engineering and Architecture to embed standards into pipelines by design


• Stay current on CDISC updates and regulatory expectations (FDA/EMA)


• Train and support other team members on standards application

Requirements

Must-haves

• 5+ years as a dedicated CDISC/SDTM/ADaM specialist (standards programming, mapping, or governance)


• Deep, hands‑on knowledge of SDTM and ADaM implementation guides


• Experience ensuring submission‑readiness for regulatory‑facing clinical data


• Excellent attention to detail and documentation discipline


• Excellent written and verbal communication skills in English

Nice-to-Haves

• CDISC certification


• Experience with USDM or protocol digitalisation standards


• Exposure to AI/ML teams translating standards into automated pipelines

Why Join Us?

• A dynamic work environment with an international team, where collaboration and diversity thrive.


• Work alongside top talent, united by a shared purpose and committed to making a real impact.


• Get equipped with a MacBook to enhance your productivity and work experience.


• Benefits package designed to support you and your family's overall well-being.


• Comprehensive medical, dental, and vision insurance options, effective from your start date or shortly thereafter depending on location.


• Hybrid work model offering flexibility to balance your professional and personal life.


• Company events to celebrate achievements and enjoy time together.


• Our office is pet-friendly! You'll likely be greeted by a few wagging tails upon arrival.

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