Biostatistical Programming Mgr

Job Description **HOW MIGHT YOU DEFY IMAGINATION?** Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role. **Biostatistical Programming Manager** **Live** **What you will do** Lets do this. Lets change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate. The Technical Manager will ensure that projects outsourced to our Functional Service Providers (FSPs) are aligned with our priorities and meet Amgen timeline, quality, data standards and compliance expectations. The Technical Manager will also provide technical consultancy to our FSPs on Amgen processes, tools and utilities. **Responsibilities:** Oversee the execution and quality of projects managed by our FSPs per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP) **Align FSP assignments with Amgen Development priorities** Ensure that FSP programming meets quality, compliance, timeline, and productivity expectations Contribute to FSP training material development and revisions, and conducting the initial training to FSP staff Provide guidance and technical consultancy to FSP Study Lead Programmers (SLP) on Amgen processes, tools, and utilities Contribute to FSP performance metrics development, data collection, and reporting Review project documentations such as specifications, issue logs, deliverable status for accuracy and completeness Advise FSP SLP on study-specific questions for specifications, documentation, and coding Lead/contribute to GSP continuous improvement initiatives **Win** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The professional we seek is proficient with these qualifications. **Basic Qualifications:** Doctorate degree OR Masters degree and 2 years of statistical programming experience OR Bachelors degree and 4 years of statistical programming experience OR Associates degree and 8 years of statistical programming experience OR High school diploma / GED and 10 years of statistical programming experience **Preferred Qualifications:** MSc in Computer Science, Statistics, Mathematics, Life Sciences or another relevant scientific subject **Regulatory submission experience** Vendor and resource management experience Familiarity with other programming languages such as R or Python **In-depth knowledge of SAS/Graph and Stat packages** Thorough understanding of data compliance checks such as Pinnacle 21 **6+ years of statistical programming in biopharmaceutical industry** Thorough understanding of clinical trial processes from data collection to analysis reporting Ability to lead programmers in successful completion of all study programming activities and provide guidance on technical and process questions Experience working in a globally dispersed team on Phase 1-4 clinical trials Excellent oral and written English communication skills; strong negotiation skills Advanced SAS analysis and reporting skills including SAS Base, macro, and SQL Hands-on experience in specifying and implementing SDTM and ADaM data sets and TFLs **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. 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** Objects in your future are closer than they appear. Join us. **** 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 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.

Created: 2024-11-05