Biostatistics Sr Mgr
On-siteHyderabad, Telangana, India
Job Summary
Lead study-level statistical deliverables with substantial independence, managing small teams and ensuring high-quality outputs that meet CfDA and regulatory expectations. Utilize expertise to inform statistical guidance for clinical development, reimbursement, and medical affairs, while planning protocol contributions, Flash Memos, and Clinical Study Reports. Implement standards for study design and analysis, oversee key documentation including TFLs and submission files, and serve as the GBS lead for the Clinical Study Team. Provide statistical consultancy, training, and advice, contribute to process improvement initiatives, and leverage AI capabilities to streamline workflows. Located in Hyderabad, India, this role supports Amgen's global biostatistics capabilities in delivering ever-better products to over 10 million patients worldwide.
Required Qualifications
- Doctorate degree in Statistics/Biostatistics or related subject with high statistical content
- At least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- Master's degree in Statistics/Biostatistics or related subject with high statistical content
- At least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- Bachelor's degree in Statistics/Biostatistics or related subject with high statistical content
- At least 14 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
- Strong verbal and written communication combined with organizational skills and cross-cultural sensitivity
- Statistical leadership and contribution to regulatory and reimbursement submissions
- Experience working effectively in a globally dispersed team environment with cross-cultural partners
Desired Qualifications
- Doctorate degree in biostatistics and at least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- Master's degree in biostatistics and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research
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