Senior Biostatistical Programmer, Biostatistician, Clinical Developer, SAS programmer (US-Remote)

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Statistical Programming, Senior Manager Live What you will do Let's do this. Let's change the world. In this vital role you will support multiple products in Amgen's Biosimilar Organization Specific responsibilities include but are not limited to: + Represent the product programming function and participate in multidisciplinary project team meetings + Collaborate closely with Biosimilar Statisticians and other functional team members + Coordinate and oversee the development of dataset specifications and implementation of TLGs according to the statistical analysis plans, work practices, and project timelines in close partnership with CROs in a full-service CRO model + Review and approve analysis dataset specifications + Review or contribute to data management plans, database development, and edit checks plan + Contribute to and review the statistical analysis plans; and results presented in IBs, protocols, clinical study reports, integrated summaries of safety/efficacy, publications, and other documents, as required; provide support and input in protocol development, case report form design, and data collection + Ensure that statistical outputs, datasets, and related documentation are archived in a clear, organized, and timely fashion according to company standards + Communicate resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally + Participate in the review of CRO Policies, SOPs and other controlled document development + Participate in the recruitment of programming staff within Biosimilar organization + Work with CRO and Amgen team to put together the submission data packages + Lead and/or contribute to the technical solutions to implement CRO programs on Amgen system and perform ad-hoc analysis to support submission and publications need + Lead and/or contribute to process improvement and operational efficiency Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The biostatistical professional we seek is a to go person with these qualifications. Basic Qualifications: + Doctorate degree and 2 years Statistical Programming in Pharmaceutical Industry experience OR + Master's degree and 6 years Statistical Programming in Pharmaceutical Industry experience OR + Bachelor's degree and 8 years Statistical Programming in Pharmaceutical Industry experience Preferred Qualifications: + Advanced SAS programming skills in processing clinical data (SAS - BASE, STAT, Macro and Graph) + Working knowledge of the latest CDISC SDTM, ADaM and Define-XML standards + In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL + Regulatory submissions experience + Thorough understanding and experience with data quality and compliance checks, e.g., Pinnacle21 + Experience of working within a global team and CRO partners to ensure operational excellence and efficiencies. + Prior staff development and project management experience and ability to train others Thrive 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 annualized base pay range for this opportunity in the U.S. is $147,047.00 - $168,947.00. 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 Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your 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. Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff. Join Us 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 cancer, 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. Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.