Senior Manager Biostatistics

Responsibilities:

• Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.

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 Amgen’s 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

Basic Qualifications :

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

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)

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

Preferred Skills :

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

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

Master’s 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.

Statistical leadership and contribution to regulatory and reimbursement submissions. of regulatory guidelines.

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