Biostatistical Programming Mgr

<h2><b>Career Category</b></h2>Clinical<h2></h2><h2><b>Job Description</b></h2><p><b>What you will do</b></p><p>Let’s do this. Let’s change the world. In this vital role you will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelor’s degree and have at least six years of relevant career experience in statistical programming. Proficiency in SQL programming and SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential.</p><p></p><p><b>Responsibilities:</b></p><ul><li><p>Provide technical solutions to programming problems within CfOR(Centre for Observational research).</p></li><li><p>Lead and develop technical programming and process improvement initiatives within CfOR</p></li><li><p>Represent the programming function and participate in multidisciplinary project team meetings</p></li><li><p>Project manage programming activities, according to agreed resource and timeline plans</p></li><li><p>Ensure programming activities adhere to departmental standards and SOPs</p></li><li><p>Write and/or review and approve programming plans</p></li><li><p>Write and/or review and approve analysis dataset specifications</p></li><li><p>Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.</p></li><li><p>Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications</p></li><li><p>Write, test, validate and execute department-, product- and protocol-level macros and utilities</p></li><li><p>Oversee the work of outsourced resources assigned to projects</p></li><li><p>Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents</p></li><li><p>Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings</p></li><li><p>Participate in the recruitment of programming staff</p></li><li><p>Actively participate in external professional organizations, conferences and/or meetings</p></li><li><p>Provide input to and participate in intra-departmental and CfOR meetings</p></li><li><p>Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&amp;D)</p></li><li><p>Manage staff performance and oversee staff assignments and utilization</p></li><li><p>Relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting</p></li></ul><p></p><p><b>What we expect of you</b></p><p>We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.</p><p></p><p><b>Basic Qualifications:</b></p><ul><li><p>Doctorate degree OR</p></li><li><p>Master’s degree and 4 to 6 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR</p></li><li><p>Bachelor’s degree and 6 to 8 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR</p></li><li><p>Diploma and 10 to 12 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience</p></li></ul><p></p><p><b>Preferred Qualifications:</b></p><ul><li><p>Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects</p></li><li><p>Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model.</p></li></ul><p>Experience:</p><ul><li><p>Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials</p></li><li><p>Team management</p></li><li><p>Global collaboration</p></li><li><p>Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery</p></li><li><p>Statistical programming: SQL required; SAS or R required; Python preferred</p></li><li><p>Experience working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV)</p></li></ul><p>Key Competencies</p><ul><li><p>Hands-on programming and lead role</p></li><li><p>Expert statistical programming knowledge using SAS or R</p></li><li><p>Required: SAS or R</p></li><li><p>Required: SQL</p></li><li><p>Preferred: Python</p></li><li><p>Excellent verbal and written communication skills in English</p></li><li><p>Ability to have efficient exchanges with colleagues across geographical locations</p></li><li><p>Agile project management</p></li><li><p>Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare</p></li><li><p>OMOP common data model</p></li><li><p>Drug development life cycle</p></li><li><p>Statistics and basic epidemiology: Incidence and prevalence</p></li><li><p>[Required for Regulatory RWE role]: CDISC (SDTM, ADaM)</p></li><li><p>Scientific / technical excellence</p></li><li><p>Oral and written communication, documentation skills</p></li><li><p>Leadership</p></li><li><p>Innovation</p></li><li><p>Teamwork</p></li><li><p>Problem solving</p></li><li><p>Attention to detail</p></li></ul><p></p><p><b>What you can expect of us</b></p><p>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.</p><p>In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.</p><p><b>Apply now</b></p><p><b>for a career that defies imagination</b></p><p>Objects in your future are closer than they appear. Join us.</p><p><b>careers.amgen.com</b></p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.