Associate Director Biostatistics

2 weeks ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 30,00,000 per year

*Responsibilities:*

  • Provide sound statistical guidance to clinical development, reimbursement, and medical affairs.
  • Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents.
  • Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies.
  • Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings.
  • Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives.
  • Provide sound statistical guidance to clinical development, reimbursement, and medical affairs.
  • Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents.
  • Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies.
  • Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings.
  • Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives.
  • Execute biostatistical strategies across the product lifecycle, from early development through post-marketing.
  • Provide consultancy and training to colleagues across R&D.
  • Support governance of outsourced statistical activities, ensuring adherence to Amgen standards and regulatory compliance.
  • Represent Biostatistics in cross-functional and external interactions (e.g., with regulatory agencies, investigators, or data monitoring committees).
  • Drive technology adoption leveraging AI capabilities to streamline statisticians work

This position is currently located at Amgen India (Hyderabad). *Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a strategic Biostatistics leader with a passion for tech-enabled transformation. Basic Qualifications :*

  • Doctorate in Statistics/Biostatistics (or related subject with high statistical content) with at least 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research, OR
  • Masters degree in Statistics/Biostatistics (or related subject with high statistical content) with at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research.

Preferred Skills :

  • Doctorate in Statistics/Biostatistics (or related subject with high statistical content) with at least 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research, OR
  • Masters degree in Statistics/Biostatistics (or related subject with high statistical content) with at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research.

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