CMC Statistics Assoc Dir

Career Category

Operations

Job Description

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.

• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The highly motivated professional we seek is a passionate individual with these qualifications.

Basic Qualifications:

• 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
   

Preferred Qualifications:

• 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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.

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Salary Range

167,899.65USD -227,158.35 USD