Senior Manager Biostatistics

What you will do

Lets do this. Lets 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 a Biostatistics Sr. Manager, you will lead study-level statistical deliverables with substantial independence. This role manages small teams, mentors staff and ensures the delivery of high-quality statistical outputs that meet CfDA and regulatory expectations.

Responsibilities:

• Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
• Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
• Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
• Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgens statistical policies, procedures and strategies.
• Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
• Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
• Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
• Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
• Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
• Provide statistical consultancy, training, and advice within Amgen
• Contributing to process improvement initiatives and operational efficiencies.
• Oversee FSP statisticians and check their contributions for quality
• Ensure statistics sections of the TMF are maintained and up-to-date
• Opportunity to manage staff, e.g. external contractors
• Opportunity to serve as a GSL for a product program
• Opportunity to serve as a product regional lead
• Contribute to and lead technology adoption leveraging AI capabilities to streamline statisticians work

This position is currently located at Amgen India (Hyderabad).

WinWhat 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 degree in Statistics/Biostatistics or related subject with high statistical content and
• At least 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research

• Masters degree in Statistics/Biostatistics or related subject with high statistical content and
• At least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research

• Bachelors degree in Statistics/Biostatistics or related subject with high statistical content and
• At least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Preferred Skills:

• Doctorate degree in biostatistics and at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research

• Masters degree in biostatistics and at least 8 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. of regulatory guidelines.
• Experience working effectively in a globally dispersed team environment with cross-cultural partners.