Principal Statistical Programmer

5 years

0 Lacs

Posted:15 hours ago| Platform: Linkedin logo

Apply

Work Mode

On-site

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 you'll 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 we're 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


At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now
Clario logo
Clario

Graphic Design

Poços de Caldas Minas Gerais

RecommendedJobs for You

kolkata, mumbai, new delhi, hyderabad, pune, chennai, bengaluru