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Bioclinica
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Principal Statistical Programmer

Principal Statistical Programmer

Bioclinica

5 - 10 years

7 - 12 Lacs

kolkata mumbai new delhi hyderabad pune chennai bengaluru

Posted:1 day ago| Platform:

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Skills Required

cro project management process improvement xml analytical data processing clinical research windows macros operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Join Clario s industry-leading Digital Physiology team as a Principal Statistical Programmer, where your expertise will drive innovation in clinical research. This is a unique opportunity to lead advanced statistical programming for cardiac safety trials, shaping the future of digital health through cutting-edge data science and global collaboration.

What we offer

Competitive compensation + shift allowances
Attractive benefits (security, flexibility, support and well-being)
Engaging employee programs
Technology for hybrid working and great onsite facilities

What youll be doing

Statistical Programming & Data Standards

Lead and coordinate all statistical programming activities for cardiac safety trials.
Develop, test, and maintain SAS code to generate CDISC-compliant datasets (SDTM, ADaM).
Produce and maintain submission-ready datasets and electronic submission packages (e.g., define.xml, reviewer s guide) in accordance with FDA guidelines.
Create and implement data standards and macros to support cardiac safety deliverables.
Research and apply new programming techniques to enhance data processing and analysis.
Generate and interpret compliance checks on CDISC-formatted datasets.
Support statistical analyses and regulatory requirements through client-facing discussions.

Team Leadership & Mentorship

Manage direct reports in a line or matrix capacity, including work allocation, resource planning, and professional development.
Conduct onboarding and training on statistical programming practices and SOPs.
Mentor junior staff and provide guidance on programming methodologies and quality standards.
Lead team strategy meetings and contribute to departmental planning.

Process Improvement & Strategic Initiatives

Identify and implement process improvements to enhance operational efficiency.
Develop and maintain SOPs, SWIs, templates, and playbooks for programming deliverables.
Drive initiatives for future analyses, data quality, and standardization.
Participate in hiring and contribute to strategic planning for the statistical programming function.

Cross-functional Collaboration & Project Management

Collaborate with cross-functional teams to define scope and timelines for statistical deliverables.
Manage client commitments and ensure timely delivery of assigned projects.
Maintain accurate tracking of deliverable statuses and dates.
Provide consultation during sponsor and regulatory teleconferences (FDA, EMEA, PMDA).

What were looking for

Ph.D. with 5+ years of relevant industry experience, M.S. with 7+ years of relevant industry experience or B.S. with 10+ years of relevant industry experience
A degree in medical, health, public, or general science or an equivalent combination of education and experience sufficient to perform job duties
Strong experience in clinical trials , preferably within a CRO or pharmaceutical research organization
Proficiency in SAS programming , including creation, testing, and maintenance of CDISC-compliant datasets (SDTM, ADaM)
Experience with electronic submission packages and regulatory interactions (e.g., FDA)
Familiarity with clinical protocols and Statistical Analysis Plans
Experience with TFL generation is a plus
Solid understanding of the pharmaceutical drug development process
Proficient in Windows and Microsoft Office products
Demonstrated leadership experience and/or training
Excellent verbal and written communication skills
Strong organizational and analytical abilities
Ability to work both independently and in a team setting , with flexibility to adapt to changing priorities

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Principal Statistical Programmer