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Senior Principal Biostatistician

7+ years
Not Disclosed
10 Nov. 27, 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

Senior Principal Biostatistician

Location: India
Job ID: REQ-10024692
Department: Biostatistics and Pharmacometrics

About the Role

The Senior Principal Biostatistician leads and oversees statistical activities for one or more clinical trials, working independently at the trial level and potentially leading statistical efforts for a development project. This role involves proposing and implementing innovative trial designs, statistical models, and data exploration methodologies, providing statistical expertise, and ensuring quality and timely statistical deliverables.

Key Responsibilities

Study Level:

  • Lead all statistical tasks for mid- to high-complexity trials.
  • Develop protocols, statistical analysis plans, and report activities.
  • Implement novel trial designs and statistical methodologies.
  • Provide statistical support for regulatory submissions, Health Authorities, and external consultants.
  • Represent Novartis in external scientific forums, congresses, and conferences.
  • Collaborate across functions to ensure alignment and effective communication.
  • Oversee all Biostatistics resources and deliverables, ensuring timeliness and quality.

Project Level:

  • Represent Biostatistics & Pharmacometrics in early project teams.
  • Collaborate with clinical, regulatory, and other functions to drive quantitative decision-making.
  • Propose innovative methods to optimize dose finding and drug development.
  • Contribute to the preparation of Health Authority meetings and advisory committees.

Franchise or Global Line Function:

  • Contribute significantly to global initiatives, process improvements, and scientific collaborations.

External Level:

  • Engage with external review boards, ethics committees, and other external parties.

People Management:

  • Mentor junior statisticians and new hires.

Minimum Requirements

  • Education: MS in Statistics (7+ years experience) or PhD in Statistics (3+ years experience).
  • Experience:
    • Expertise in all statistical tasks at the trial/experiment level.
    • Proficiency with SASR, and knowledge of drug development and Health Authority guidelines.
    • Expertise in pharmacokinetics, exposure-response modeling, or Bayesian statistics (depending on assignment).
  • Skills:
    • Strong project management, leadership, and collaboration skills.
    • Ability to work with non-statistical functions and explain statistical concepts clearly.

Why Novartis?

At Novartis, we believe in creating a community of smart, passionate people who collaborate to achieve breakthroughs that improve patients' lives. Join our team and contribute to advancing innovative science.

Benefits and Rewards

Novartis offers comprehensive benefits, including career development opportunities, professional growth, and competitive compensation. For more details, visit Novartis Benefits and Rewards.

Join Our Network

If this role isn't right for you, join the Novartis Talent Network to stay connected and learn about future opportunities: Novartis Talent Network.