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Amgen · 5 days ago
Biostatistics Sr Manager
United States
Full-time
Remote
Senior Level
8+ years exp
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Responsibilities
Executes key projects, deliverables, and operational tasks related to biostatistical strategy, technical expertise, and reporting within designated studies/products.
Utilizes knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
Implements, oversees, and supports standards, technical quality, and consistent approaches in strategy, study design, and statistical analysis.
Plans and executes statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs).
Provides statistical inputs to clinical publications and regulatory documents.
Oversees statistical work performed by study statisticians.
Performs statistical analysis of multiple 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. provides 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 the 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.
Stays abreast of the latest developments in the field of statistics in drug development (innovative trial design).
Contributes to process improvement and operational efficiency.
Adheres to all Amgen Policies, Standard operating procedures (SOPs).
Qualification
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Required
Doctorate degree in Statistics/Biostatistics and at least 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research or related subject with high statistical content
Master’s degree in Statistics/Biostatistics and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research or related subject with high statistical content
Preferred
Doctorate degree in Statistics/Biostatistics and at least 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research or related subject with high statistical content
Master’s degree in Statistics/Biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research or related subject with high statistical content
Statistical leadership and contribution to regulatory or reimbursement submissions
Experience working effectively in a globally dispersed team environment with cross-cultural partners
Excellent oral and written English communication skills
Ability to manage self, lead and manage others in the successful and timely completion of all statistical activities for a study or multiple studies from end to end
Ability to effectively perform complex statistical analyses and related tasks
Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
Benefits
Full support and career-development resources
A diverse and inclusive community
Generous Total Rewards Plan
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10,001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (349)
2022 (523)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-24IPO· nasdaq:AMGN
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Judy Brown
SVP Corporate Affairs
Recent News
2024-06-05
MarketScreener
2024-06-05
Company data provided by crunchbase
