Senior Manager Biostatistics

Amgen Technology; Hyderabad; Presencial; INR 2 500 000 - 6 500 000; Tempo integral

Resumo da oferta

Amgen India in Hyderabad is seeking a Biostatistics Sr. Manager to lead study-level statistical deliverables with substantial independence and to mentor staff.

The role includes guiding protocols, CSRs, and regulatory submissions while ensuring high-quality analyses for publications and internal use. You will oversee multiple statistical projects, collaborate cross-functionally with clinical development, medical affairs and reimbursement teams, and contribute to innovative trial designs and

Qualificações

• Doctorate or Master's level with strong statistical content required.
• Experience in pharmaceutical industry or medical research is essential.
• Strong leadership and mentoring abilities preferred.

Responsabilidades

• Lead study-level statistical deliverables with substantial independence.
• Mentor staff and ensure delivery of high-quality outputs.
• Plan and contribute to protocols, Flash Memos and CSRs.
• Oversee data analysis plans, listings, figures, and submission data files.
• Collaborate cross-functionally to deliver robust analysis results for publications and regulatory submissions.

Conhecimentos

Statistical leadership

Cross-cultural communication

Global team collaboration

Regulatory submission experience

Formação académica

Doctorate degree in Statistics/Biostatistics or related subject with high statistical content

Master's degree in Statistics/Biostatistics or related subject with high statistical content

Descrição da oferta de emprego

HOW MIGHT YOU DEFY IMAGINATION

If you feel like youre part of something bigger, its 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 worlds leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Biostatistics Sr. Manager

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).

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 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 (OR)

• Masters degree in Statistics/Biostatistics or related subject with high statistical content and
• At least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Preferred Skills

• Doctorate degree in biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research (OR)

• Masters degree in biostatistics and at least 12 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.

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

• Vast opportunities to learn and develop within our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits