Biostatistics Sr Mgr

Amgen • Thousand Oaks, CA

21h

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Biostatistics Senior Manager What you will do Let’s do this. Let’s change the world. 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 Senior Biostatistics Manager 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. Will also influence and supply to strategy development, defend statistical approaches and represent GBS (Global Biostatical Science) through participating in and collaborating with multidisciplinary project teams. Specific duties include: Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs. Implementing, managing and supporting standards, technical quality and consistent approaches in 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 all aspects of work performed by study statisticians. Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations. Anticipating and communicating resource and quality challenges that could impact results or timelines. Solid understanding of regulatory guidelines in drug development. Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies. Contributing to process improvements and operational efficiencies.

Requirements

• Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 2 years of Biostatistics experience OR Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 4 years of Biostatistics experience OR Bachelor’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 6 years of Biostatistics experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience
• Solid understanding of regulatory guidelines in drug development.

Nice To Haves

• Doctorate degree in biostatics or statistics
• 5 or more years of pharma/biotech statistical experience.
• Life cycle drug development experience (pre-clinical, clinical and post-marketing).
• Experience with cardiovascular 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 (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