Statistical Programmer
us biomedical india pvt
📍 Remote🌐 Remote🕐 1mo ago🔗 workday
Job Description
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.