Amgen
Regulatory RWE Programming Senior Manager
Amgen, Newbury Park, California, United States, 91320
Biostatistical Programming Senior Manager
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us. Live What You Will Do The Biostatistical Programming Senior Manager within the Center for Observational Research (CfOR) provides leadership and technical expertise to the Regulatory RWE programming team in the development and execution of real-world evidence (RWE) observational studies and ensures adequate and timely delivery of results. The individual will report to the Director of the Regulatory RWE Programming team in CfOR and is responsible for operational oversight of team projects in addition to planning, organizing, and managing resources to ensure high-quality and timely delivery of observational research programming deliverables. Leads and contributes to efforts to identify, develop, and implement departmental standards, applications, processes, and training. This position requires the management of a geographically distributed technical team, as well as a broad, comprehensive understanding of statistical programming languages and platforms, real-world data, claims and EMR databases, and current regulatory data standards. CfOR leads Amgen's strategic effort to effectively demonstrate RWE to conduct observational research studies and help increase the efficiency of drug development and drug commercialization. CfOR at Amgen partners with teams to generate RWE supporting a wide variety of business needs for multiple collaborators across the product lifecycle. Evidence generation activities include but are not limited to studies regarding the frequency and distribution of disease, the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, treatment cost, and utilization patterns, and the safety and efficiency of therapeutic interventions. This Senior Manager will be responsible for operational oversight of Regulatory RWE Programming team projects within the Data and Analytics Center (DAC). This role is located on the Amgen corporate campus in Thousand Oaks, CA, with remote opportunities also considered. Key Activities include: Oversight of regulatory filing analyses using Real World Evidence (RWE) to ensure compliance with both internal procedures and external regulations Development and implementation of data standards and study processes for use in regulatory filings containing RWE Execute and lead the programming for observational research studies across multiple types of data including medical claims, electronic health records, and survey data Work cross-functionally to establish and maintain priorities on projects and allocate staff and FSP external workers to projects in alignment with business and product priorities Communicate and interpret technical, and scientific information to a variety of audiences Effective people management, through staff development, engagement, and performance management Implement innovative ways for working with Big Data in healthcare, such as using common data models, data visualization, and efficiency initiatives in large databases Basic Qualifications: Doctorate degree and 2 years of statistical programming in the pharmaceutical industry experience OR Master's degree and 6 years of statistical programming in the pharmaceutical industry experience OR Bachelor's degree and 8 years of statistical programming in the pharmaceutical industry experience OR Preferred Qualifications: Master's degree in Epidemiology, Biostatistics, Computer Science, or other subject with high statistical content 8+ years of relevant statistical programming experience Previous experience with regulatory filings, especially where RWE was included Experience applying CDISC standards to Real-World Data, or mapping Real-World Data to other common data models Experience managing programming teams 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors, including but not limited to, relevant skills, experience, and qualifications. 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. 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.
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us. Live What You Will Do The Biostatistical Programming Senior Manager within the Center for Observational Research (CfOR) provides leadership and technical expertise to the Regulatory RWE programming team in the development and execution of real-world evidence (RWE) observational studies and ensures adequate and timely delivery of results. The individual will report to the Director of the Regulatory RWE Programming team in CfOR and is responsible for operational oversight of team projects in addition to planning, organizing, and managing resources to ensure high-quality and timely delivery of observational research programming deliverables. Leads and contributes to efforts to identify, develop, and implement departmental standards, applications, processes, and training. This position requires the management of a geographically distributed technical team, as well as a broad, comprehensive understanding of statistical programming languages and platforms, real-world data, claims and EMR databases, and current regulatory data standards. CfOR leads Amgen's strategic effort to effectively demonstrate RWE to conduct observational research studies and help increase the efficiency of drug development and drug commercialization. CfOR at Amgen partners with teams to generate RWE supporting a wide variety of business needs for multiple collaborators across the product lifecycle. Evidence generation activities include but are not limited to studies regarding the frequency and distribution of disease, the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, treatment cost, and utilization patterns, and the safety and efficiency of therapeutic interventions. This Senior Manager will be responsible for operational oversight of Regulatory RWE Programming team projects within the Data and Analytics Center (DAC). This role is located on the Amgen corporate campus in Thousand Oaks, CA, with remote opportunities also considered. Key Activities include: Oversight of regulatory filing analyses using Real World Evidence (RWE) to ensure compliance with both internal procedures and external regulations Development and implementation of data standards and study processes for use in regulatory filings containing RWE Execute and lead the programming for observational research studies across multiple types of data including medical claims, electronic health records, and survey data Work cross-functionally to establish and maintain priorities on projects and allocate staff and FSP external workers to projects in alignment with business and product priorities Communicate and interpret technical, and scientific information to a variety of audiences Effective people management, through staff development, engagement, and performance management Implement innovative ways for working with Big Data in healthcare, such as using common data models, data visualization, and efficiency initiatives in large databases Basic Qualifications: Doctorate degree and 2 years of statistical programming in the pharmaceutical industry experience OR Master's degree and 6 years of statistical programming in the pharmaceutical industry experience OR Bachelor's degree and 8 years of statistical programming in the pharmaceutical industry experience OR Preferred Qualifications: Master's degree in Epidemiology, Biostatistics, Computer Science, or other subject with high statistical content 8+ years of relevant statistical programming experience Previous experience with regulatory filings, especially where RWE was included Experience applying CDISC standards to Real-World Data, or mapping Real-World Data to other common data models Experience managing programming teams 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors, including but not limited to, relevant skills, experience, and qualifications. 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. 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.