Statistical Programmer

Posted 2 Hours Ago
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Hiring Remotely in Bangalore, Bengaluru Urban, Karnataka, IND
In-Office or Remote
Mid level
Healthtech • Software
The Role
Develop, validate, and maintain CDISC-compliant SDTM and ADaM datasets (including ECG/ ADEG), SAS programs, and regulatory submission packages. Perform double programming and dataset validation, generate compliance checks, create Define.xml and reviewer guides, support cardiac safety analyses, train team members, manage project timelines, and contribute to SOPs and process improvements for clinical trial deliverables.
Summary Generated by Built In

At Clario, a part of Thermo Fisher Scientific, our Cardiac Solutions team supports clinical trials worldwide through the delivery of high-quality statistical programming, analysis datasets, and regulatory submission packages. As a Statistical Programmer, you will play a key role in developing and validating CDISC-compliant datasets, supporting cardiac safety analyses, and ensuring regulatory-ready deliverables are produced with accuracy and efficiency. This role is ideal for a collaborative programming professional who enjoys working with clinical trial data and contributing to the development of life-changing therapies.

What We Offer

  • Competitive pay and incentives

  • Provident fund and medical insurance

  • Engaging employee programs and local events

  • Modern office spaces and remote work flexibility

What You'll Be Doing

  • Produce, validate, and maintain submission-ready datasets to support cardiac safety clinical trials, including SDTM ECG (EG) and ADaM ADEG datasets.

  • Create, test, and maintain SAS programs used to generate and validate CDISC-compliant datasets.

  • Develop, test, and implement data standards that support cardiac research and regulatory submissions.

  • Perform double programming and validation activities to ensure the accuracy of statistical analysis datasets.

  • Generate and interpret compliance checks for CDISC-formatted datasets, including SDTM and ADaM standards.

  • Support research initiatives by providing programming expertise and analysis results to senior team members and department leadership.

  • Create electronic submission packages, including Define.xml, reviewer guides, and supporting regulatory documentation in accordance with FDA submission requirements.

  • Train team members on standard operating procedures, programming standards, and best practices.

  • Identify and implement process improvements to enhance operational efficiency and data quality.

  • Manage project timelines and client commitments to ensure on-time delivery of assigned deliverables.

  • Maintain accurate project status, milestones, and deliverable tracking information.

  • Contribute to the development and maintenance of SOPs, Standard Work Instructions (SWIs), checklists, playbooks, templates, and quality standards.

  • Collaborate with cross-functional teams to define programming requirements and support project-level statistical deliverables.

  • Support onboarding and training of new team members and promote knowledge sharing across the organization.

What We Look For

  • Bachelor's degree in Statistics, Mathematics, Computer Science, Biostatistics, or a related quantitative discipline with 3+ years of relevant experience; or Master's degree with 0–1 years of relevant experience.

  • Experience working within a pharmaceutical company, Contract Research Organization (CRO), or clinical research environment.

  • Strong SAS programming experience, including the development and maintenance of clinical trial datasets.

  • Experience creating, validating, and maintaining CDISC-compliant datasets, including SDTM and ADaM standards.

  • Understanding of clinical trial protocols, Statistical Analysis Plans (SAPs), and the pharmaceutical drug development process.

  • Experience supporting regulatory submission activities and deliverables preferred.

  • Strong analytical, problem-solving, and data validation skills.

  • Excellent verbal and written communication skills.

  • Strong organizational skills with the ability to manage multiple projects and priorities simultaneously.

  • Proficiency with Microsoft Office applications and Windows-based software environments.

  • Ability to work independently and collaboratively within cross-functional teams.

  • Adaptability and flexibility in a fast-paced environment with changing priorities.

At Clario, 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.

Skills Required

  • Bachelor's degree in Statistics, Mathematics, Computer Science, Biostatistics, or related quantitative discipline with 3+ years of relevant experience (or Master's with 0-1 years).
  • Experience working within a pharmaceutical company, CRO, or clinical research environment.
  • Strong SAS programming experience for developing and maintaining clinical trial datasets.
  • Experience creating, validating, and maintaining CDISC-compliant datasets, including SDTM and ADaM standards (including SDTM ECG/EG and ADaM ADEG).
  • Understanding of clinical trial protocols, Statistical Analysis Plans (SAPs), and the pharmaceutical drug development process.
  • Experience supporting regulatory submission activities and deliverables.
  • Experience creating electronic submission packages (Define.xml, reviewer guides) in accordance with FDA submission requirements.
  • Strong analytical, problem-solving, and data validation skills.
  • Excellent verbal and written communication skills.
  • Strong organizational skills and ability to manage multiple projects and priorities.
  • Proficiency with Microsoft Office applications and Windows-based software environments.
  • Ability to work independently and collaboratively within cross-functional teams; adaptability in changing priorities.

Clario Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Clario and has not been reviewed or approved by Clario.

  • Leave & Time Off Breadth Time off is described as generous, including flexible PTO for some roles and up to 26–31 PTO days for eligible staff. The calendar includes 15 paid company holidays and a Winter Break.
  • Healthcare Strength Healthcare offerings include multiple medical plan options via Highmark with coordinated care navigation, plus dental and vision through established carriers. Employer HSA contributions and mental-health support broaden the package.
  • Inclusive Benefits Coverage Coverage highlights include domestic-partner eligibility, transgender-inclusive care, and HIV prevention/treatment. These inclusive elements are presented alongside broader inclusion commitments.

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The Company
HQ: Philadelphia, NJ
6,733 Employees
Year Founded: 1972

What We Do

-- Clario has been named a Top Workplace by Energage for the 2022 Top Workplaces USA national awards. -- Clario generates the richest clinical evidence by fusing our deep scientific expertise and global scale into the broadest endpoint technology platform. By doing this, we empower our partners to transform lives. With almost 50 years of experience, 19,000 clinical trials, and 870 regulatory approvals, Clario has mastered the ability to generate rich evidence across a Trial Anywhere™ portfolio: decentralized (DCT), hybrid and site-based clinical trials. With 30 facilities in nine countries across North America, Europe, and Asia Pacific, Clario delivers the power of certainty. Partners ————— Clario brings the best of ERT and Bioclinica together to work alongside our partners to solve some of their biggest questions on topics such as: - eCOA vs. paper - Decentralized Clinical Trial (DCT) - Rescue a clinical trial - Broad endpoint technology: cardiac safety, imaging, respiratory And many more. People ———— We are so honoured to be named a 2022 Top Workplace by Energage. One of our leading values at Clario is People First Always. We help individuals build meaningful careers at Clario as they serve to help transform patients lives. Join us on this journey and check out our careers page: https://clario.com/careers/

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