Biostatistical Programming Manager - Oncology

Job SummaryThe Biostatistical Programming Manager will work in Amgen's Global Statistical Programming (GSP) organization in the Oncology Therapeutic area & can be based at Amgen's headquarters in Thous& Oaks, California or at Amgen's South San Francisco or Seattle, Washington locations. Responsibilities include:- Function as study lead programmer on one or more Phase 2 & 3 clinical trials:o set up the study-level programming environmento project-manage programming activities on the study, ensuring quality & timelinesso ensure all programming activities on the study adhere to required st&ardso represent GSP & provide input to multidisciplinary team & department meetings- Create, or review & approve, programming specifications & plans at the study level- Review & approve key study-related documents produced by other functions, such as case report forms, data management plan, & statistical analysis plan- Write & validate SAS programs using CDISC st&ards to produce permanent datasets & presentation-ready output, to be included in reports for submission to regulatory agencies, publications & other communications- Underst& & execute department, product, & study-level macros & utilities- Write & validate study & product-level macros & utilities- Assist with study & systems audits by Global Compliance Auditing (GCA) & external bodies, & respond to audit questions & findings- Participate in or lead technical programming & process improvement initiatives within & across functions- Participate in the development & review of GBDS policies, manuals, st&ard operating procedures, & other controlled documents- May manage & develop a small number of programming staff- Provide support to & mentor more junior programmers- Participate in the recruitment of GSP staff & contractors- Promote & communicate awareness of biostatistical programming & the role of the GSP department in internal & external professional organizations, conferences, training, or meetingsBasic Qualifications:Doctorate degree ORMaster's degree 3 years of directly related experienceORBachelor's degree 5 years of directly related experienceORAssociate's degree 10 years of directly related experiencePreferred Qualifications:Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Life Sciences or other related scientific subjectSix (6) years clinical research & development programming experienceOncology therapeutic area programming experience CDISC experienceDrug Development (pre-, early, late &/or observational) in related industriesProject planningProcess improvement participationTeam participation & effectivenessKnowledge:Biostatistical programming using the SAS System version 8. 2 or higherUnderst&ing of computer operating systems, including UNIX preferredProject planning & managementDrug development process operations