Associate Director Biostatistics

2 days ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 20,00,000 - ₹ 25,00,000 per year

What you will do 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 Amgens 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 Amgens 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 statisticians work

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.

  • Associate Director Biostatistics

    1 week 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,...

  • Associate Director Biostatistics

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 15,00,000 - ₹ 30,00,000 per year

    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...

  • Associate Director, Biostatistical Programming

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Associate Director, Biostatistical ProgrammingHOW 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...

  • Associate Director, Biostatistical Programming

    1 week ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Career CategoryResearchJob DescriptionAssociate Director, Biostatistical Programming 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...

  • Associate Director, Biostatistical Programming

    2 days ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    What you will doAmgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As an Associate Director of Biostatistical Programming (Programming Execution Lead), you will partner with Global Programming Leads (GPL) and lead a large offshore team of Study...

  • Associate Director Biostatistics

    1 week 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,...

  • Associate Director, Biostatistical Programming

    2 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Key Responsibilities:Accountable and responsible for ensuring successful execution and delivery of GSP milestone analysis deliverables and regulatory submission packages for a group of high priority and/or high complexity Amgen products being supported by the offshore programming team.Work with GPL to ensure successful implementation of programming...

  • Associate Director

    4 days ago

    Hyderabad, Telangana, India Deloitte Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job requisition ID :: 92817Date: Nov 19, 2025Location: HyderabadDesignation: Associate DirectorEntity: Deloitte Touche Tohmatsu India LLP

  • Associate Director-Real World Evidence

    5 days ago

    Hyderabad, Telangana, India Novartis Full time ₹ 15,00,000 - ₹ 30,00,000 per year

    Job Description SummaryThe Associate Director, Real-World Evidence role focuses on operational execution of Non-Interventional Studies (NIS) and Real-World Evidence (RWE) generation projects to support US Medical Affairs strategic priorities across all priority therapeutic areas. This role leads a team of RWE professionals in Hyderabad, building internal...

  • Biostatistical Programming Sr Mgr

    1 week ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Career CategoryClinicalJob Description Let's do this. Let's change the world. In this vital role you will be responsible for developing and leading teams in their collaboration with epidemiological and programming colleagues across multiple time zones to ensure request fulfilment, clarify requirements, track projects, resolve issues, and deliver high-quality...