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Clario

Systems Analyst II

Posted 5 Hours Ago
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Remote
Hiring Remotely in India
Mid level
Remote
Hiring Remotely in India
Mid level
As a Systems Analyst II, you'll create and maintain non-standard data files, develop CDISC-compliant datasets, and collaborate across departments to support clinical trials and regulatory submissions.
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As a Systems Analyst II on our eCOA team, you’ll play a critical role in turning complex clinical trial data into high‑quality, submission‑ready evidence. At Clario, a part of Thermo Fisher Scientific, this role sits at the intersection of advanced SAS programming, CDISC standards, and cross‑functional collaboration—supporting cardiac safety trials, regulatory submissions, and innovative data solutions that help bring therapies to patients faster. If you enjoy solving complex data challenges while mentoring others and influencing best practices, this role offers both technical depth and meaningful impact.

This role supports U.S. East Coast business hours; candidates must be willing and able to work U.S. Eastern Time or closely aligned hours on a regular basis.

What We Offer

  • Competitive compensation and annual performance bonus

  • Provident Fund and comprehensive medical insurance for you and eligible dependents

  • Paid time off including vacation, sick leave, and public holidays

  • Employee wellness programs and engagement activities

  • Professional development through internal and external training and certification programs

What You’ll Be Doing

  • Create, maintain, and test code used for non‑standard data file creation as well as CDISC SDTM and ADaM datasets.

  • Serve as a programming resource for Clinical Data Operations and other departments, including creation of statistical and submission‑ready datasets and SQL Server engineering support.

  • Attend client meetings, as appropriate, to understand protocol‑specific data collection and reporting requirements.

  • Receive and review standard Clario and non‑Clario client file specifications; collaborate with Data Managers, Project Managers, and clients to finalize transfer specifications.

  • Develop, validate, and document programs to generate CDISC‑compliant SDTM and ADaM datasets.

  • Create submission‑ready cardiac safety datasets, including SDTM EG, ADaM ADEG, define.xml, and Dataset Reviewers’ Guides to support regulatory submissions.

  • Participate in the Software Development Life Cycle, including unit testing, test script development, execution, and peer code reviews.

  • Process data extracts; review and execute encoding requests; run encoding programs; and archive studies in accordance with internal standards.

  • Perform ad‑hoc programming activities using raw data to support: Advanced and esoteric quality control checks, Data review, resolution, and mining, Treatment‑emergent flags and SAP‑driven specifications and Other client‑specific requirements

  • Provide programming support to Data Management activities, including data review.

  • Prepare for and participate in internal and external audits.

  • Work across multiple service lines and modalities, collaborating closely with cardiologists, data managers, project managers, and other subject‑matter experts.

  • Support new product initiatives and minimum viable product (MVP) solutions through cross‑functional collaboration.

  • Identify opportunities to improve methodologies and contribute practical solutions that enhance quality, efficiency, and effectiveness.

  • Mentor Systems Analyst I team members and contribute to training, process development, and SOP review activities.

What We Look For

  • Bachelor’s or Master’s degree in Informatics, Mathematics, Computer Science, or a related field.

  • SAS Certified Specialist: Base Programming (required); SAS Certified Professional: Advanced Programming (preferred).

  • 3+ years of experience in a pharmaceutical company or CRO as a SAS Programmer, with strong hands‑on experience in SAS/BASE, SAS/MACRO, and SAS/SQL.

  • 1+ year of experience in database design and data structures.

  • Solid understanding of the pharmaceutical drug development process, supported by 2+ years of relevant industry experience.

  • Proven experience working with large, complex, real‑world patient datasets.

  • Extensive experience implementing CDISC SDTM standards and Define; working knowledge of EG, CO, RE, and QS domains is highly desirable.

  • Knowledge of technical and regulatory requirements related to clinical data programming.

  • Strong time‑management skills with the ability to support multiple projects and competing timelines.

  • Excellent written and verbal communication skills; fluency in English (spoken and written).

  • Experience with Windows and Microsoft Office products.

  • Experience with database programming is a plus.

  • Demonstrated ability to mentor junior team members and assist with training delivery.

At Clario, a part of Thermo Fisher Scientific, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.

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