Biostatistics Sr Mgr

Amgen • Denver, CO

1d • $154,104 - $208,494

About The Position

Amgen is seeking a Biostatistics Senior Manager to join their team. This role is responsible for leading sophisticated studies and projects in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience). The Senior Biostatistics Manager will ensure statistical aspects of clinical activities meet required standards, influence strategy development, and represent Global Biostatistical Science (GBS) on multidisciplinary project teams. Key duties include providing statistical guidance, implementing standards, planning and executing statistical contributions to protocols and reports, performing statistical analysis, and staying current with regulatory guidelines and statistical developments.

Requirements

• Doctorate degree and 2 years of Biostatistics experience OR Master’s degree and 6 years of Biostatistics experience OR Bachelor’s degree and 8 years of Biostatistics experience
• Solid understanding of regulatory guidelines in drug development.

Nice To Haves

• Doctorate degree in biostatistics or statistics.
• 5 or more years of pharma/biotech statistical experience.
• Life cycle drug development experience (pre-clinical, clinical and post-marketing).
• Experience with oncology drug development.
• Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
• Strong verbal and written communication combined with organizational skills and cross-cultural sensitivity
• Statistical leadership and contribution to regulatory and reimbursement submissions.
• Strong working knowledge of theoretical and applied statistics and of regulatory guidelines.
• Experience working effectively in a globally dispersed team environment with cross-cultural partners.

Responsibilities

• Independently leads sophisticated studies and projects in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid.
• Influences and supplies to strategy development, defends statistical approaches and represents GBS through participating in and collaborating with multidisciplinary project teams.
• Utilizes knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
• Implements, manages 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 input for clinical publications and regulatory filing documents.
• Leads all aspects of work performed by study statisticians.
• Performs statistical and exploratory analysis of studies/projects and develops conclusions and recommendations.
• Anticipates and communicates resource and quality challenges that could impact results or timelines.
• Stays current in developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
• Contributes to process improvements and operational efficiencies.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree