[3 Days Left] Senior Associate Biostatistical Programming

Career Category Research Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people s lives A biotechnology pioneer since 1980 Amgen has grown to be one of the world s leading independent biotechnology companies has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential Observational research OR is an increasingly important component in drug development and commercialization because in the current environment there is increased demand for information from OR studies for regulatory and reimbursement authorities The Center for Observational Research CfOR at Amgen partners with teams to generate real world evidence for multiple stakeholders across the product lifecycle CfOR contributes evidence regarding the frequency and distribution of disease or the clinical burden of disease the natural history or clinical course of disease the design of clinical trials cost and utilization patterns and the safety and effectiveness of interventions What will you do Let s do this Let s change the world In this vital role you will collaborate with teams across multiple time zones to fulfill requests clarify requirements escalate issues and deliver high-quality results The Sr Associate Biostatistical Programming will report to a locally based Biostatistical Programming Manager The Sr Associate Biostatistical Programming will be responsible for hands-on programming and results delivery Additionally they 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 four 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 Responsibilities Write test and validate software programs in Unix and Databricks to produce analysis datasets and presentation output such as tables and figures to be included in reports for submission to regulatory agencies publications and other communications Provide technical solutions to programming problems within CfOR Centre for Observational research Lead and develop technical programming and process improvement initiatives within CfOR Represent the programming function and participate in multidisciplinary project team meetings Manage all programming activities according to agreed resource and timeline plans Ensure all programming activities on the project adhere to departmental standards Write and or review and approve all programming plans Write and or review and approve analysis dataset specifications Review and approve key study-related documents produced by other functions e g SAPs CRF Data Management Plan etc Write test validate and execute department- product- and protocol-level macros and utilities Lead and or participate in the development and review of CfOR policies SOPs and other controlled documents Participate in study and systems audits by Clinical Quality Assurance CQA and external bodies and respond to audit questions and findings Participate in the recruitment of programming staff Actively participate in external professional organizations conferences and or meetings Provide input to and participate in intra-departmental and CfOR meetings Contribute to the continuous improvement of programming CfOR and Research and Development R D Manage staff performance and oversee staff assignments and utilization What we expect of you 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 Basic Qualifications Master s degree and 1 to 3 years of Computer Science Statistics Mathematics Life Sciences Economics or other relevant scientific subject experience OR Bachelor s degree and 3 to 5 years of Computer Science Statistics Mathematics Life Sciences Economics or other relevant scientific subject experience OR Diploma and 7 to 9 years of Computer Science Statistics Mathematics Life Sciences Economics or other relevant scientific subject experience Preferred Qualifications Experience in SQL and statistical programming using SAS or R Master s degree in Computer Science Statistics Mathematics Life Sciences Economics or other relevant scientific subject Training or experience using the Observational Medical Outcomes Partnership OMOP common data model Real-world evidence RWE generation in pharmaceutical or related research industries or statistical programming for clinical trials Strong individual contributor proficient in developing analysis datasets identifying data anomalies and ensuring program accuracy Global collaboration on studies to clarify and implement analyses described in Statistical Analysis Plans Project fulfillment statistical programming issue escalation results delivery Statistical programming SQL required SAS or R required Python preferred Motivated to learn how to work with real-world healthcare data RWD such as healthcare claims MarketScan Optum Clinformatics Medicare and EHR databases Optum EHR PanTher Flatiron CPRD MDV Key Competencies Hands-on programming role Expert statistical programming knowledge using SAS or R Required SAS or R Required SQL Preferred Python Excellent verbal and written communication skills in English Ability to have efficient exchanges with colleagues across geographical locations Agile project management Real-world data RWD including insurance claims databases electronic medical records and patient registries for example MarketScan Optum PharMetrics Flatiron Medicare OMOP common data model Drug development life cycle Statistics and basic epidemiology Incidence and prevalence Required for Regulatory RWE role CDISC SDTM ADaM Scientific technical excellence Oral and written communication documentation skills Leadership Innovation Teamwork Problem solving Attention to detail Learning mindset Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering developing manufacturing and delivering innovative human therapeutics This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people s lives A biotechnology pioneer since 1980 Amgen has grown to be one of the world s leading independent biotechnology companies has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential