Associate Director Biostatistics

Amgen Inc

5 - 10 years

20 - 25 Lacs

hyderabad

Posted:3 hours ago| Platform:

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Skills Required

compliance pharmaceutical industry regulatory filings medical pharmaceutical ai process improvement regulatory compliance research marketing r design statistical analysis statistics

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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