[{"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15650BR\nJob Posting Title Sr Mgr Biostatistics\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Senior Manager Biostatistics will implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis\n\u2022Plan and execute statistical contributions to Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications\n\u2022Complete statistical analysis of multiple studies/projects\n\u2022Hire, manage and develop statistical staff\n\u2022Contribute to resource and budget planning\n\u2022Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)\n\u2022Be familiar with statistical policy and strategy at Amgen\n\u2022Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field\n\u2022Promote and communicate statistical awareness and the role of the Global Biostatistics department, and may contribute to statistical consultancy, statistical training and expert advice within Global Biostatistics and within Amgen\n\u2022Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents\n\u2022Participate in study and systems audits conducted by Amgen CQA and external bodies, and respond to audit questions and findings\n\u2022May lead and/or participate in change / process improvement initiatives\n\u2022May participate in external activities (e.g. Industry, academic)\nBasic Qualifications .Doctorate degree & 2 years of directly related experience\nOR\n.Master\u2019s degree & 6 years of directly related experience\nOR\n.Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nAND\n. 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications Minimum 8 years relevant career experience in the pharmaceutical/biotechnology industry,\nwith Bachelor\u2019s degree (MS/MA degree preferred) in Biostatistics, Statistics, Computer\nScience, Mathematics, Life Sciences, or other relavent scientific subject\nStrong project planning and management skills - the ability to lead and manage cross-functional projects from concept to completion, being proactive and taking initiative, striking balance between strategic and tactical thinking, the ability to handle complex tasks, and deliver according to agreed timelines\nStrong verbal and written communication skills - ability to clearly and effectively present information, demonstrate creativity and foresight in anticipating and solving complex project issues\nDisplays personal ownership - a natural innovator who is always looking for opportunities to improve systems or processes\nTrack record of generating new ideas and solutions to business problems, and the vision and tenacity to translate that vision into quantifiable results\nTakes steps to ensure the ongoing technical development", "date_new": "2012-05-08 18:44:22", "url": "http://www.amgen.jobs/xml/28541377/job", "country": "United States", "company": "Amgen", "title": "Sr Mgr Biostatistics", "reqid": "15650BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28541377}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15528BR\nJob Posting Title Principal Scientist - Cardiovascular Discovery Research\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science\u2019s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people\u2019s lives.\n\nA new position is available in the Department of Metabolic Disorders at Amgen. The Amgen cardiovascular research group in Metabolic Disorders is looking for a highly motivated principal scientist with experience in biopharmaceutical discovery research and/or academic basic research to join them in their R&D facility in Thousand Oaks, CA.\n\nThe successful candidate will have the primary responsibility of leading a large animal cardiovascular physiology laboratory, focusing on models of heart failure and arrhythmias. This individual must have strong technical skills in such models, and the candidate\u2019s primary responsibility will be hands on implementation and critical interpretation of experiments required to assess compound efficacy using state of the art techniques and methods. The successful candidate must also possess the communication/managerial skills along with the level of expertise such needed to teach relevant techniques to less experienced colleagues and reports.\n\nThe successful candidate will need to work effectively in a fast-paced environment, have the ability to multi-task and work effectively with multiple groups (internal and external to Amgen), have strong oral and written communication skills, and be self-motivated. This position will report directly to the Executive Director of the Cardiovascular Discovery Research Group at Amgen.\nBasic Qualifications Doctorate degree & 5 years of scientific experience\nOR\nMaster\u2019s degree & 12 years of scientific experience\nOR\nBachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications The ideal candidate will have an MD or PhD in a scientific discipline, e.g,. physiology or pharmacology. A minimum of 5 to 10 years or more industrial experience in cardiovascular physiology using models of disease to interrogate the efficacy of therapeutic agents. Hands-on experience with canine models of heart failure and arrhythmias in support of early and late stage preclinical drug discovery projects is highly desirable.\nThe ideal candidate will specifically have hands-on experience with cardiovascular imaging techniques (e.g. echocardiography) and invasive assessment of cardiovascular hemodynamics in large animals. The ideal candidate will also have excellent communication and teaching skills required to head a small group of scientists working interactively within a highly matrixed research environment.", "date_new": "2012-05-04 19:32:51", "url": "http://www.amgen.jobs/xml/28441231/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist - Cardiovascular Discovery Research", "reqid": "15528BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28441231}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15148BR\nJob Posting Title Sr Mgr Biostatistics\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description \u2022implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis\n\u2022Plan and execute statistical contributions to Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications\n\u2022Complete statistical analysis of multiple studies/projects\n\u2022Hire, manage and develop statistical staff\n\u2022Contribute to resource and budget planning\n\u2022Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)\n\u2022Be familiar with statistical policy and strategy at Amgen\n\u2022Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field\n\u2022Promote and communicate statistical awareness and the role of the Global Biostatistics department, and may contribute to statistical consultancy, statistical training and expert advice within Global Biostatistics and within Amgen\n\u2022Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents\n\u2022Participate in study and systems audits conducted by Amgen CQA and external bodies, and respond to audit questions and findings\n\u2022May lead and/or participate in change / process improvement initiatives\n\u2022May participate in external activities (e.g. Industry, academic)\nBasic Qualifications .Doctorate degree & 2 years of directly related experience\nOR\n.Master\u2019s degree & 6 years of directly related experience\nOR\n.Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nAND\n.2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications Minimum 8 years relevant career experience in the pharmaceutical/biotechnology industry,\nwith Bachelor\u2019s degree (MS/MA degree preferred) in Biostatistics, Statistics, Computer\nScience, Mathematics, Life Sciences, or other relavent scientific subject\nStrong project planning and management skills - the ability to lead and manage cross-functional projects from concept to completion, being proactive and taking initiative, striking balance between strategic and tactical thinking, the ability to handle complex tasks, and deliver according to agreed timelines\nStrong verbal and written communication skills - ability to clearly and effectively present information, demonstrate creativity and foresight in anticipating and solving complex project issues\nDisplays personal ownership - a natural innovator who is always looking for opportunities to improve systems or processes\nTrack record of generating new ideas and solutions to business problems, and the vision and tenacity to translate that vision into quantifiable results\nTakes steps to ensure the ongoing technical development", "date_new": "2012-04-17 20:12:41", "url": "http://www.amgen.jobs/xml/27953376/job", "country": "United States", "company": "Amgen", "title": "Sr Mgr Biostatistics", "reqid": "15148BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27953376}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15158BR\nJob Posting Title Scientist - Chemical Process Research and Development\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description A Scientist in the CPR&D Department (Chemical Process Research and Development) is responsible for development of the technology enabling manufacture of Amgen\u2019s drug substance candidates from pre-clinical to commercial scales. The Scientist will participate in drug substance development teams and be expected to develop innovative solutions to prepare Amgen drug substances.\n\nKEY RESPONSIBILITIES*:\n\nSCIENTIFIC/TECHNICAL\n\u2022 Develop technology to deliver Amgen\u2019s API candidates in a practical, efficient and safe manner.\n\u2022 Participate in drug substance teams and collaborate cross-functionally with analytical and drug product representatives to delivery drug substance manufacturing processes in a phase appropriate manner.\n\u2022 Work cross-functionally to deliver CMC regulatory documents and supporting documentation in support of Amgen\u2019s small molecule regulatory filings.\n\u2022 Work with external partners to deliver key intermediate or drug substances in support of Amgen\u2019s small molecule pipeline.\n\u2022 Deliver processes amenable to cGMP operation and carry out deliveries of drug substance in a cGMP manufacturing environment.\n\nTEAM EXPERIENCE\n\u2022 Demonstrates ability to effectively participate on drug substance development teams as a team member or primary department representative\n\u2022 Represents the department in various departmental and interdepartmental committees that address scientific and administrative initiatives\n\u2022 Participates in and can direct team efforts directed at advancing development/technology programs within the department\n\u2022 Applies team experiences to facilitate cohesiveness and build team spirit\n\nORAL AND WRITTEN COMMUNICATION\n\u2022 Authors, or provides direction for the authorship of, technical reports or regulatory submissions which may require minimal additional editing.\n\u2022 Gives effective presentations within the department and to senior management with minimal supervision.\n\u2022 Actively creates, generates, and presents paper/presentations at scientific meetings.\n\u2022 Capable of organizing and conducting effective meetings.\n\u2022 Learns and applies facilitation and listening skills.\n\nSUPERVISING OTHERS [MAY HAVE DIRECT REPORT(S)]\n\u2022 Ensures that safe laboratory practices are followed.\n\u2022 Trains less-experienced staff.\n\u2022 Demonstrates ability to direct the activities of others.\n\nLEADERSHIP AND INFLUENCE\n\u2022 Identifies resources and develops timelines for project activities.\n\u2022 Learns to organize, plan, and control multiple project activities effectively to meet corporate timelines.\n\u2022 Effectively and actively participates on one or more project team with demonstrated ability to occupy a leadership role.\nBasic Qualifications \u2022 Master\u2019s degree & 4 years of scientific experience\nOR\n\u2022 Bachelor\u2019s degree & 6 years of scientific experience\nPreferred Qualifications \u2022 Ph.D. in Organic Chemistry and 0-5 years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams\n\u2022 A BS Scientist with a minimum of 10+ years pharmaceutical industry or MS scientist 8+ years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams.\n\u2022 Experience with the techniques associated with the synthesis, purification and characterization of organic molecules\n\u2022 Experience with protein expression in E. coli and intein or sortase technology\n\u2022 Experience with large molecule purification techniques\n\u2022 Experience with synthetic organic techniques applied to peptides\n\u2022 An scientific track record which may include peer reviewed publications, scientific conference participation\n\u2022 Experience with the use of analytical instruments (HPLC, NMR, IR and MS) and interpreting the scientific data based upon these techniques.\n\u2022 Demonstrated communication and scientific writing skills.", "date_new": "2012-04-06 21:47:28", "url": "http://www.amgen.jobs/xml/27706681/job", "country": "United States", "company": "Amgen", "title": "Scientist - Chemical Process Research and Development", "reqid": "15158BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27706681}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13954BR\nJob Posting Title Scientist\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.\n\nAs an organization dedicated to improving the quality of life for people around the globe, Amgen fosters an inclusive environment of diverse, committed and highly accomplished people. People who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.\n\nWe are currently seeking a Scientist for our Clinical Immunology group.\n\nThis role will:\n\n\u2022 Design and execute specific scientific experiments for development, validation and implementation of methods capable of detecting anti-drug neutralizing antibodies or for measurement of drug biological activity in clinical and nonclinical study samples\n\n\u2022 Develop and implement new and novel protocols to address specific issues and/or troubleshoot and improve currently existing assays towards being more sensitive, transferable, and high-throughput\n\n\u2022 Conduct data analysis and interpretation, and assesses impact of the data on the project\n\n\u2022 Provide technical support and expertise to department operating groups when needed\n\n\u2022 Represent the department on cross-functional project teams\n\n\u2022 Provide scientific oversight to transfer of assays to CROs\n\n\u2022 Assist senior-level Scientists in managing clinical and/or non-clinical programs\n\n\u2022 Contribute as lead author on scientific documents such as journal publications, technical reports, etc.\nBasic Qualifications Doctorate degree\n\nOR\n\nMaster\u2019s degree & 3 years of directly related experience\n\nOR\n\nBachelor\u2019s degree & 5 years of directly related experience\nPreferred Qualifications A successful candidate in this role should:\n\n\u2022 Post doc experience preferred\n\n\u2022 Demonstrate innovation in cell signaling, in vitro assay design\n\n\u2022 Be able to solve complex problems demonstrating a deep understanding in a scientific area of expertise.\n\n\u2022 Demonstrate ability to drive scientific excellence and innovation.\n\n\u2022 Knowledge of the drug development process\n\n\u2022 Have the ability to effectively present scientific information both internally and externally to influence decisions and/or scientific practices\n\n\u2022 Demonstrate knowledge of the IND/NDA process\n\n\u2022 General knowledge of the field of Immunology, Oncology, Immunochemistry, or Cell Biology and pertinent immunologic assays.\n\n\u2022 Experience in in vitro cell-based assays and related technologies, in-depth knowledge of signal transduction processes.\n\n\u2022 Development, validation, transfer and implementation of assays detecting and characterizing antibodies to protein products in biological matrices and/or measuring drug activity.\n\n\u2022 Development, validation, transfer and implementation of fluorescence-based assays in cell lines, animal model and/or human specimens in collaboration with analysts and scientists in a variety of clinical / therapeutic areas.\n\n\u2022 Project Management as it pertains to oversight of vendors, assay transfers and implementation of outsourced assays.\n\n\u2022 Ability to communicate complex ideas to audiences with varying degrees of knowledge\n\n\u2022 Initiative\n\n\u2022 Attention to detail\n\n\u2022 Independence of thought demonstrated through hypothesis formulation, experimental design, interpretation and innovation\n\n\u2022 Demonstrated critical thinking with an ability to integrate data and information to solve complex problems\n\n\u2022 Ability to collaborate on a functional and/or cross-functional team as a leader and/or a member\n\n\u2022 Ability to build and manage a team", "date_new": "2012-02-17 19:39:09", "url": "http://www.amgen.jobs/xml/26597026/job", "country": "United States", "company": "Amgen", "title": "Scientist", "reqid": "13954BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26597026}]