- 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 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 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 operation procedures (SOPs). We are all different, yet we all use our unique contributions to serve patients. The Biostatistical professional we seek is an emerging leader with these qualifications. Basic Qualifications
- 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
- Masters 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 contentPreferred Qualifications
- 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
- Masters 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 influenceThriveSome of the vast rewards of working here 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.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on GlassdoorApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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Biostatistics Sr Manager - Washington D.C., United States - Amgen
Description
In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of CfDA (Center for Design & Analysis). The Biostatistics Senior Manager independently leads multiple studies, ensures that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct, influences and contributes to the development strategy, and defends statistical approaches internally and externally.
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