Biostatistics Mgr

The Biostatistics Manager in Biosimilar Development co-ordinates/performs the design, statistical analysis and reporting of individual studies, represents Biostatistics on study teams and provides statistical input for publications, presentations and in-house decision-making.

Responsibilities

• Provides statistical contributions, statistical review and quality control of Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications in close partnership with CROs in a full-service CRO model.
• Influences study design and defends statistical approaches internally and externally.
• Ensures all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct.
• Oversees the work of outsourcing partners and vendors for statistical services.
• Performs statistical analysis of individual studies/projects and subsequent exploratory analyses and makes sound conclusions and recommendations.
• Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g. provide support and input in case report form design, and data collection)
• Proactively anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
• Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines and industry practice
• Stays abreast of latest developments in the field of statistics in drug development and contributing to scientific advances by publishing applied research in scientific journals and books and presenting statistical methodology at internal or external scientific meetings.
• Participates in the review of CRO Policies, SOPs and other controlled document development; contributes to process improvement and operational efficiency.
• Adheres to all Amgen Policies, Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development.

Basic Qualifications:

Doctoral degree in Statistics/Biostatistics or other subject with high statistical content

OR

Currently enrolled in PhD program in Statistics/Biostatistics or other subject matter with high statistical content, and must complete all requirements necessary to obtain Doctoral Degree in the PhD program prior to employment start date

OR

Master's degree in Statistics/Biostatistics or other subject with high statistical content and 3 years of statistics experienc

Preferred Qualifications:

• Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
• Ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
• Ability in presenting results and defending statistical findings, study design and analysis. This could be to internal audiences (study/product team) or at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings
• Ability in working within a global team and with CRO partners to ensure operational excellence and efficiencies
• Demonstrated effective communication skills (written and oral)

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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