Specialist CMC Statistician (US Remote)
- West Greenwich, RI
- Start date
- Mar 21, 2023
- Science/R&D, Biostatistics, CMC
- Required Education
- Associate Degree
- Position Type
- Full time
- Pharm Country, Best Places to Work
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Specialist CMC Statistician (US Remote)Live
What you will do
Lets do this! Lets change the world! In this vital role, you will contribute to Amgens pipeline of new molecules and commercial products, that are treating serious illnesses and transforming lives. You will contribute on our Global CMC Statistics (GCS) team, which is focused on designing, developing, and promoting best practices, processes and tools across Operations that drive consistency and improve compliance.
As part of the GCS team, this role implements statistical tools and techniques to support product manufacturing and testing throughout the product life cycle. Also, provides support to clinical and commercial manufacturing sites within the network. This involves statistical support for analyzing Operations generated data including supervising programs, analytical methods, investigations, and other ad-hoc analyses as required.
In this role, you will also support development of delivery devices and systems, and provide statistical analysis, study designs, acceptance sampling plans and acceptance criteria for the development, qualification, and transfer of physical test methods. You will establish appropriate study designs and carry out evaluation of acceptance criteria for Design Verification testing ensuring that the overall program is aligned with Amgen and Regulatory/ISO requirements.Primary Responsibilities Include:
- Provides continuous statistical support to a site or functional group by collaborating with technical associates to develop an experimental study, perform statistical analysis, and document results in a technical report that aligns with Amgens document control system and has statistical integrity.
- Provides written responses to clarify and/or explain a statistical approach and performs additional analysis to support regulatory submissions and response to questions, as required.
- Participates in the development, implementation and maintenance of statistical tools used to support product life cycle activities assisting with drafting/updating white papers, writing standardized SAS code, outlining report templates, and aligning GCS duties in relevant SOPs.
- Participates in improvement efforts to promote statistical techniques used in biologics and monoclonal antibodies processes; and mentors and guides statistical techniques and software tools to technical associates.
- Stays up to date on biotechnology industry trends, best practices, guidance documents and participates in external conferences, as appropriate.
- Contributes to continuous improvement efforts across Amgens networks, leading to harmonization, efficiency gains and scientific innovation, as well as administration of statistical training for Amgens engineers and scientists.
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 collaborate partner with these qualifications.Basic Qualifications:
- Associate's degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 10 years of experience OR
- Bachelor's degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 5 years of experience OR
- Masters degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 3 years of experience OR
- Doctorate degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics
- Advanced degree in Applied or Industrial Statistics with 3 years experience applying statistical methodologies to support Biopharma manufacturing and control.
- Proficient in statistical tools and techniques commonly used in biopharma manufacturing and testing 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 our teammates professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $121,859 - $146,713.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.
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.
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
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