CMC Statistics Assoc Dir

Amgen • Thousand Oaks, CA

2d

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. CMC Statistics Assoc Dir What you will do Let’s do this. Let’s change the world. In this vital role you will contribute to Amgen’s pipeline of new molecules and commercial products, that are treating serious illnesses and transforming lives. The Associate Director will be a member of the Global CMC Statistics (GCS) team. The mission of the team is to design, develop and promote best practices, processes and tools across Operations that drive consistency and enhance compliance. As part of the Global CMC Statistics team, the Associate Director will use their expertise to implement statistical tools and techniques to support product manufacturing and testing throughout the product life cycle. The statistician will also provide support to clinical and commercial manufacturing sites in the network. This involves statistical support for monitoring programs, analytical methods, and investigations. Ad-hoc statistical support will be provided for root-cause analysis for protocol or method deviations. The Associate Director will support the development of delivery devices, and provide statistical analysis, study designs, acceptance sampling plans and acceptance criteria for the development, qualification, and transfer of physical test methods. They will also establish appropriate study designs and carry out evaluation of acceptance criteria for Design Verification testing ensuring that the overall program is compliant with Amgen and Regulatory/ISO requirements, and support component and material qualifications using process capability analysis and equivalence tests. Finally, the candidate will contribute to continuous improvement efforts across Amgen’s networks, leading to harmonization, efficiency gains and scientific innovation and administration of statistical training for Amgen’s engineers and scientists.

Requirements

• Doctorate degree and 3 years of Applied Statistics, Industrial Statistics or Non-clinical Biostatistics experience OR Master’s degree and 5 years Applied Statistics, Industrial Statistics or Non-clinical Biostatistics experience OR Bachelor’s degree and 7 years of Applied Statistics, Industrial Statistics or Non-clinical Biostatistics experience OR Associate’s degree and 12 years of Applied Statistics, Industrial Statistics or Non-clinical Biostatistics experience OR High school diploma / GED and 14 years of Applied Statistics, Industrial Statistics or Non-clinical Biostatistics experience

Nice To Haves

• Advanced degree in Applied or Industrial Statistics with 5 years’ experience applying statistical methodologies to Biopharma manufacturing and control
• Proficient in statistical tools and techniques commonly used in biopharma manufacturing operations, such as, Design of Experiments, Statistical Process Control, Process Capability Analysis, Measurement System Analysis, Acceptance Sampling Plans, Non-linear and Linear Regression, Significance Tests, and Simulation.
• Proficient in SAS programming (data manipulation techniques, macro, statistical and graphical PROCs, and ODS) and JMP statistical software
• Excellent interpersonal, oral, and written communication skills

Responsibilities

• Drive improvements/standardization in one or more key areas of statistical analysis
• Use Amgen-provided Artificial Intelligence (AI) tools to enhance existing business processes
• Reviews and provides quality oversight of technical documents.
• Supports the development and review of SOPs and other controlled documents within Amgen or CROs for process improvement and operational efficiency.
• Guides the development, implementation and maintenance of statistical tools used to support product life cycle activities, such as drafting/updating white papers, writing standardized SAS code, outlining report templates, and aligning GCS duties in relevant SOPs.
• Drives statistical thinking as a leader of cross functional teams
• Drives the development and implementation of innovative strategies and technologies in a cross functional role.
• Considered a business or scientific-technical SME.
• Responsible for staying up to date on scientific and industry trends, developing new techniques and plans, and understanding company goals and competitor practices.
• Have advanced disciplinary and basic industry knowledge, in-depth understanding of project management techniques and business interdependencies, and the ability to contribute to scientific and innovative advances in the field.
• Participate in external conferences, as appropriate, and be aware of the guidance documents and best practices in the biotechnology industry.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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: Director
• Education Level: Ph.D. or professional degree