Principal Biostatistician

Information Technology
India
May 13, 2025
Full Time
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Job Description

As a Principal Biostatistician at Novartis, you will function a key statistical expert for clinical trials and development applications. You’ll be liable for designing and analyzing research, interpreting statistics, and supplying strategic statistical enter to aid evidence-based regulatory submissions, clinical decisions, and market get right of entry to strategies.

This function offers high visibility and the risk to collaborate cross-functionally with clinicians, information scientists, regulatory teams, and senior management.

🛠️ Key Responsibilities

  • Lead statistical planning and execution for scientific trials and applications
  • Provide strategic enter into clinical improvement plans and regulatory submissions
  • Design clinical studies with suitable statistical methodologies and endpoints
  • Collaborate on protocol improvement, statistical evaluation plans, and statistics assessment
  • Conduct and interpret statistical analyses for medical trial information
  • Ensure accuracy, reproducibility, and compliance with regulatory standards (e.G., ICH, FDA, EMA)
  • Communicate statistical findings sincerely to inner stakeholders and regulatory bodies
  • Mentor junior statisticians and aid practical excellence tasks
  • Represent Biostatistics in cross-purposeful task teams and advisory forums

✅ Required Qualifications

🎓 Education:

  • Ph.D. Or Master’s diploma in Statistics, Biostatistics, Mathematics, or a related quantitative area

💼 Experience:

  • At least 6–8 years of applicable enjoy in medical trial biostatistics, preferably in the pharmaceutical or biotech enterprise
  • Proven information in designing and analyzing Phase I-IV clinical trials
  • Strong understanding of regulatory necessities (e.G., ICH-GCP, FDA/EMA guidance)

🧠 Technical Skills:

  • Proficient in statistical software (e.G., SAS, R, or Python)
  • Experience with CDISC standards (SDTM, ADaM)
  • Excellent problem-fixing and analytical abilties
  • Ability to translate complex statistical principles into actionable insights
  • Strong written and verbal communique skills

🌟 Preferred Qualifications

  • Experience working on worldwide improvement applications and regulatory submissions (e.G., NDA, BLA, MAA)
  • Familiarity with Bayesian methodologies, adaptive trial design, or system studying approaches
  • Experience in particular therapeutic regions (e.G., Oncology, Cardiovascular, Rare Diseases)
  • Publication history in peer-reviewed journals or active participation in statistical institutions (e.G., ASA, PSI)

🌐 Why Join Novartis?

At Novartis, you’re no longer simply filling a function—you’re advancing technology that could change lives. The Principal Biostatistician position gives the danger to contribute to global healthcare innovation at the same time as building a fulfilling, intellectually stimulating career.

Benefits Include:

  • Competitive reimbursement package and overall performance-based totally bonuses
  • Flexible running arrangements (hybrid or far off)
  • Comprehensive health, dental, vision, and well being blessings
  • Retirement and savings plans
  • Career improvement packages, training, and international mobility possibilities
  • Inclusive lifestyle devoted to diversity, fairness, and inclusion

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