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Amgen Inc
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Associate Director Biostatistics

Associate Director Biostatistics

Amgen Inc

5 - 10 years

20 - 25 Lacs

hyderabad

Posted:4 weeks ago| Platform:

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Skills Required

pharmaceutical drug safety medical research pharmacovigilance clinical research medical writing molecular biology biotechnology scientific writing microbiology clinical data management medical affairs patient care clinical trials life sciences

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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Associate Director Biostatistics