Biostatistical Programming Manager

Career Category Clinical Development 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. 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. Biostatistical Programming Manager Duties: Drive Case Report Form design and data collection strategy within the Clinical Study Team to influence it for purpose data collection decisions while ensuring successful analysis and submission; Review Study Data Tabulation Model (SDTM) datasets and related specification and submission documents for analysis and regulatory submissions; Provide Clinical Data Interchange Standards Consortium expertise and guidance to the Clinical Study Team including the Global Statistical Programming team and cross functional partners for implementation and mapping; Author and review Study Data Tabulation Model submission files; Review Study Data Tabulation Model data conformance checks output and study team dispositions on selected snapshots as determined by need and perform Study Data Tabulation Model audit for all pivotal snapshots; Support global standards level content management and impact analysis; and Support cross-functional development of global standard, Therapeutic Area, and product-level Case Report Forms. May telecommute. Requirements: Master’s degree (or foreign equivalent) in Applied Science, Mathematics, or a related field & completion of a university-level course, research project, internship, or one year of experience in the following: 1. Creating and managing annotated Case Report Forms (CRFs), reviewer’s guides, and conformance documentation using controlled terminology and CDISC SDTM implementation guides; 2. Applying project management principles to coordinate timelines, deliverables related to applications that promote automation and harmonization of SDTM production across the portfolio, and cross-functional dependencies to ensure timely report completion; 3. Collaborating with external stakeholders, including Functional Service Providers (FSPs), Contract Research Organizations (CROs), or contingent workers to deliver study-level programming outputs including SDTM domains, CSDRG, Define.xml, and aCRF; 4. Working with clinical trial datasets to support regulatory submissions and internal analysis across different phases of clinical studies; 5. Preparing submission-ready datasets and documentation following CDISC and regulatory standards, including data mapping and ad hoc analyses; 6. Programming in statistical languages, including SAS, R, and Python, to develop and validate clinical data outputs; and 7. Designing and programmatically developing automation tools for process improvement related to automation and harmonization of SDTM production across the portfolio. Contact: Interested candidates please apply via https://careers.amgen.com/en/search-jobs and search for job # R-244949 Job type: Full Time position. The annual salary for this position in the U.S. is $133,952.00– $192,690.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/ 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. 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 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, including remote and hybrid work arrangements, where possible 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. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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. Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.