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Principal Statistical Programmer

0-2 years
Not Disclosed
10 Oct. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Principal Statistical Programmer

Job ID: REQ-10060750
Location: Hyderabad, India
Division: Development
Business Unit: Innovative Medicines
Employment Type: Full-time, Regular
Shift: No


Summary

The Principal Statistical Programmer is responsible for all statistical programming, data review reporting, and analytics development for multiple studies, medium-to-large projects, or project-level activities.

The role acts as a key collaborator and strategic partner to ensure efficient execution of drug-development plans with high-quality and timely deliverables, adhering to internal and regulatory standards. It also oversees programming style, statistical reporting quality, and timeline compliance.


Key Responsibilities

Statistical Programming & Data Analytics

  • Lead statistical programming activities across multiple studies or projects.

  • Implement data analytics reports and propose strategies at study or project level.

  • Ensure standardization of project-level programming solutions and knowledge sharing.

  • Develop and validate datasets and outputs for regulatory submissions, safety reports, publications, and post-marketing activities.

Team Leadership & Mentorship

  • Act as a functional manager for local associates, providing supervision, advice, and expertise.

  • Mentor and inspire team members to solve problems and leverage innovation opportunities.

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

Innovation & Problem Solving

  • Act as an expert in problem-solving within projects and functional communities.

  • Lead or co-lead novel projects and generate innovative ideas within teams or project groups.

Compliance & Reporting

  • Ensure adherence to Novartis policies, SOPs, and regulatory guidelines.

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

  • Oversee the distribution of marketing samples, if applicable.


Key Performance Indicators

  • High quality, timely, cost-efficient deliverables.

  • Customer and partner satisfaction.

  • Compliance with Novartis policies and guidelines.


Minimum Requirements / Skills

Work Experience:

  • Biostatistics

  • Clinical Research Phases

  • R&D Portfolio Management

  • Statistical Programming

  • Data Management & Systems

  • Regulatory Submissions

  • Innovative & Analytical Technologies

  • Clinical Trial Design, Data Review & Reporting

Skills:

  • Classification Systems

  • Clinical Trials

  • Computer Data Storage & Programming

  • Cross-Functional Team Collaboration

  • Data Analysis & Data Structures

  • Initiative & Problem-Solving

  • Reporting & Statistical Analysis

Languages:

  • English


Commitment to Diversity & Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities served.

Accessibility & Accommodation

Reasonable accommodations are available for individuals with disabilities during recruitment or to perform essential job functions. Contact: diversityandincl.india@novartis.com with the job requisition number and details of your request.


Why Novartis?

Novartis reimagines medicine to improve and extend people’s lives. Its associates drive innovation and collaboration to achieve breakthroughs that change patients’ lives.