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Director Statistical Programming

0-2 years
Not Disclosed
10 Feb. 19, 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: Director, Statistical Programming
Job ID: REQ-10040551
Location: Hyderabad, India (also available in Mumbai, India)
Company: Novartis Healthcare Private Limited


About the Role:

The Director, Statistical Programming will provide expertise under the Global Head of Statistical Programming, focusing on quality, CDISC standards, automation, open-source capabilities, and data structures for modeling. The role requires extensive experience in drug development, GCP, and regulatory requirements.


Key Responsibilities:

  • Leadership & Team Development:

    • Lead and mentor a high-performing team.

    • Responsible for performance management, feedback, professional development, and training.

    • Foster collaboration, innovation, and trust across the team and with cross-functional groups.

  • Productivity & Efficiency:

    • Drive productivity and efficiency measures to meet AQS strategic goals and targets.

    • Ensure the team’s performance meets or exceeds expectations, and take corrective actions when necessary.

  • Statistical Programming Strategy:

    • Lead the development of future strategies and processes within AQS.

    • Contribute to the continuous improvement of statistical programming processes.

    • Enhance statistical programming practices and drive innovations across therapeutic areas.

  • Regulatory & Compliance:

    • Ensure all projects comply with industry standards (e.g., CDISC) and regulations.

    • Monitor audit readiness and manage risks effectively.

    • Participate in Health Authority inspections and audits.

  • Collaborative Projects:

    • Lead and support global clinical and non-clinical projects.

    • Manage high-quality communication and information flow on deliverables to stakeholders.

  • Capability Building:

    • Identify and support the development of technical and soft skills for Statistical Programming associates.


Key Performance Indicators

  • Meet goals for quality, compliance, and programming/reporting standards.

  • No critical inspection/audit findings attributed to Statistical Programming.


Minimum Requirements:

  • Educational Background: University or college degree in life science, computer science, statistics, or a relevant field.

  • Experience:

    • Proven leadership and organizational skills.

    • In-depth understanding of clinical trial methodology, GCP, and medical terminology.

    • Demonstrated ability to manage multiple deliverables and meet deadlines.

  • Skills:

    • Strong leadership, collaboration, and communication skills.

    • Ability to drive business and technical innovations while ensuring compliance with industry standards.


Why Novartis?

  • Innovative Science: Join a community of passionate individuals focused on breakthroughs that change patients' lives.

  • Diversity & Inclusion: Novartis is committed to creating an inclusive and diverse work environment.

  • Benefits & Rewards: Explore Novartis' comprehensive benefits and rewards for personal and professional growth. Learn more here.


How to Apply

To apply for this position, visit the Novartis Career Portal.


Additional Information

  • Accessibility: For reasonable accommodation due to a medical condition or disability, please contact diversityandincl.india@novartis.com.


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