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Senior Principal Biostatistician

10+ years
Not Disclosed
10 Nov. 28, 2024
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

Global System Integration Expert – Novartis (REQ-10027504)

Location: Hyderabad, India
Division: Operations
Functional Area: Quality
Employment Type: Full-time, Regular

Key Responsibilities:

  • Manage quality aspects and ensure compliance with cGMP, QA agreements, regulatory requirements, and Novartis Quality Manual.
  • Develop and maintain system integrations via TetraScience Data platform using DataWeave programming.
  • Create custom pipelines to transfer data from laboratory systems to LIMS.
  • Establish and update global documentation (SOPs, user guides).
  • Support planning, execution of system updates/releases, and Computer System Validation (CSV).
  • Contribute to laboratory operations strategy and ensure timely deliverables.

Key Requirements:

  • Education: Degree in Pharmacy, Engineering, Chemistry, or equivalent.
  • Experience:
    • 10+ years in pharma laboratory operations.
    • Expertise in DataWeave programming and Labware LIMS.
    • Strong knowledge of cGMP and regulatory compliance.
    • Experience with risk assessment and management.
  • Skills: Project management, technical expertise in lab systems, effective communication, and collaboration.

Senior Principal Biostatistician – Novartis (REQ-10024692)

Location: Hyderabad, India
Division: Development
Functional Area: Research & Development
Employment Type: Full-time, Regular

Key Responsibilities:

  1. Study-Level Responsibilities:

    • Oversee statistical tasks for mid-to-high complexity trials, including protocol development, SAP, and reporting activities.
    • Plan and execute exploratory and biomarker analyses.
    • Represent Biostatistics in cross-functional teams and external forums.
  2. Project-Level Responsibilities:

    • Support quantitative decision-making for drug development programs.
    • Collaborate with clinical and regulatory teams on trial designs and analysis.
    • Lead statistical deliverables for submissions and Health Authority interactions.
  3. Franchise and Enterprise Contributions:

    • Drive process improvement initiatives and modern trial designs.
    • Represent Novartis in external discussions, publications, and conferences.
  4. Mentorship:

    • Guide new hires and junior statisticians.

Key Requirements:

  • Education:
    • MS in Statistics (7+ years’ experience) or Ph.D. in Statistics (3+ years’ experience).
  • Experience:
    • Expertise in clinical trial statistics, regulatory requirements, and health authority guidelines.
    • Proficiency in statistical tools (e.g., SAS, R).
  • Skills:
    • Strong project management and leadership.
    • Excellent collaboration and communication with cross-functional teams.

Key Competencies for Both Roles:

  • Collaboration across boundaries.
  • Adherence to quality and regulatory standards.
  • Effective communication and decision-making.