Associate Director Biostatistics

23 hours ago

Hyderabad, Telangana, India Amgen Full time ₹ 15,00,000 - ₹ 45,00,000 per year
Career CategoryResearchJob Description HOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission -to serve patients - drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.Associate Director BiostatisticsWhat you will doLet's do this. Let's change the world.Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. As Associate Director, Biostatistics, you will contribute statistical strategy, operational execution, and scientific leadership across Amgen's clinical programs. You will oversee statistical contributions to clinical trials, lead study teams, and support regulatory and reimbursement submissions, while mentoring and managing statisticians.This role provides both hands-on technical leadership and managerial responsibility, ensuring quality, compliance, and innovation in biostatistical delivery aligned with Amgen's global clinical development strategy.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 statistician's work
This position is currently located at Amgen India (Hyderabad).WinWhat we expect of youWe 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
  • Master's 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
  • Master's 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.
ThriveWhat you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and develop within our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
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