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Principal Statistical Programmer

5 years
Not Disclosed
10 Sept. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

(Title not specified in text – suggest: Lead Statistical Programmer / Associate Director – Statistical Programming)


About the Role

As a key member of the Novartis Development team, you will lead statistical programming activities across multiple studies and projects. You will play a pivotal role in driving innovation, ensuring quality deliverables, and supporting regulatory submissions, publications, and other clinical development activities.


Major Accountabilities

  • Leadership & Strategy

    • Lead statistical programming activities for multiple studies/projects.

    • Propose strategies and make decisions at study or project level.

    • Act as functional manager for local associates, providing supervision, coaching, and process expertise.

  • Collaboration & Communication

    • Build and maintain effective working relationships with cross-functional teams.

    • Represent programming in study/project-level discussions on deliverables, timelines, and resources.

    • Ensure project-level standardization and knowledge sharing.

  • Programming & Problem-Solving

    • Provide and implement programming solutions to meet study/project requirements.

    • Act as subject-matter expert in complex problem-solving situations.

    • Ensure timely development and validation of datasets and outputs for:

      • Regulatory submissions/interactions

      • Safety reports

      • Publications

      • Post-marketing activities

  • Innovation & Mentorship

    • Lead/co-lead innovative projects within the team.

    • Generate and implement novel ideas across teams and functions.

    • Mentor, inspire, and support others in problem-solving.

  • Compliance & Reporting

    • Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.

    • Oversee distribution of marketing samples (where applicable).


Key Performance Indicators (KPIs)

  • Delivery of high-quality, timely, and cost-efficient outputs.

  • Adherence to Novartis policies, guidelines, and regulatory standards.

  • Positive customer and partner feedback.


Minimum Requirements

Work Experience

  • Biostatistics and Clinical Research Phases

  • R&D Portfolio Management

  • Statistical Programming and Data Management Systems

  • Regulatory Submissions

  • Clinical Trial Design, Data Review, and Reporting

  • Application of Innovative & Analytical Technologies

Skills

  • Statistical Analysis & Reporting

  • Programming Languages (e.g., SAS, R, Python)

  • Data Analysis, Data Structures, and Computer Programming

  • Cross-Functional Collaboration

  • Initiative and Problem-Solving Skills

  • Knowledge of Classification Systems and Computer Data Storage

Languages

  • English (required)


Why Novartis

At Novartis, helping people with disease and their families takes more than innovative science—it takes a community of smart, passionate people. Here, you will collaborate, support, and inspire one another to create breakthroughs that change patients’ lives.


Benefits and Rewards

We’re committed to helping you thrive personally and professionally.


Join Our Talent Network

Not the right role for you? Stay connected and learn about future opportunities: Novartis Talent Network


Position Details

  • Division: Development

  • Business Unit: Innovative Medicines

  • Location: Hyderabad, India

  • Company / Legal Entity: IN10 Novartis Healthcare Private Limited

  • Functional Area: Research & Development

  • Job Type: Full-time

  • Employment Type: Regular

  • Shift Work: No


Accessibility & Accommodation

Novartis is committed to providing reasonable accommodations to individuals with disabilities. If you require assistance during the recruitment process or to perform essential job functions, please email: diversityandincl.india@novartis.com (include job requisition number).


Diversity & Inclusion

We are committed to building an inclusive workplace and diverse teams that represent the patients and communities we serve.