Biostatistics Sr Mgr

Amgen • Denver, CO

2d

About The Position

Amgen is seeking a Biostatistics Senior Manager to join their team. This role involves leading sophisticated studies and projects in General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring statistical aspects meet required standards. The Senior Biostatistics Manager will also influence strategy development, defend statistical approaches, and represent Global Biostatistical Science (GBS) on multidisciplinary project teams. Key responsibilities include providing statistical guidance for clinical development, reimbursement, and medical affairs; implementing and supporting standards for strategy, study design, and statistical analysis; planning and executing statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs); providing input for clinical publications and regulatory filing documents; leading the work of study statisticians; performing statistical and exploratory analyses; and anticipating and communicating resource and quality challenges. The role requires a solid understanding of regulatory guidelines in drug development and staying current with advancements in biostatistics and Amgen's policies. Contributions to process improvements and operational efficiencies are also expected.

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.
• Strong working knowledge of theoretical and applied statistics and of regulatory guidelines.

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.
• 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 (Global Biostatical Science) 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