Job
Description
Role Overview: As a Senior Manager of Biostatistical Programming at Amgen, you will play a crucial role in expanding the Global Statistical Programming capabilities, with a focus on supporting integrated delivery across regions. Your primary responsibility will be to partner with the Global Programming Lead and lead an offshore team to ensure successful execution of end-to-end programming activities for products within or across therapeutic areas. You will be instrumental in overseeing Global Statistical Programming study results and drug approval submission activities for the assigned product areas. Key Responsibilities: - Accountable for successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for assigned products - Collaborate with the Global Programming Lead to implement programming strategies and industry requirements globally - Plan, monitor progress, and address issues related to projects effectively - Provide input on resource plans and budgets for Global Statistical Programming at the product level - Monitor and utilize assigned staff efficiently according to priorities - Lead process improvement initiatives and participate in cross-functional working groups - Assist in study and system audits and inspections - Develop, review, and implement Policies, SOPs, and other controlled documents affecting Global Statistical Programming globally - Provide hands-on support to the assigned product areas - Offer coaching and mentoring to local programming staff - Provide input into career development plans for all staff on assigned projects Qualifications Required: - BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or related field, with at least 8 years of statistical programming experience in a clinical development environment - Strong technical, communication, and leadership skills - Ability to lead and manage programmers effectively for timely completion of programming activities - Experience in developing an offshore statistical programming team - Advanced analysis and reporting skills in SAS, including SAS/STAT, Macro, Graph, SQL, etc. - Previous regulatory submission experience - Proficiency in data quality and compliance checks - Experience in software development and working in a globally dispersed team environment - Staff development leadership and project management experience - Excellent oral and written English communication skills Additional Details: The position will be located at Amgen India (Hyderabad). Role Overview: As a Senior Manager of Biostatistical Programming at Amgen, you will play a crucial role in expanding the Global Statistical Programming capabilities, with a focus on supporting integrated delivery across regions. Your primary responsibility will be to partner with the Global Programming Lead and lead an offshore team to ensure successful execution of end-to-end programming activities for products within or across therapeutic areas. You will be instrumental in overseeing Global Statistical Programming study results and drug approval submission activities for the assigned product areas. Key Responsibilities: - Accountable for successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for assigned products - Collaborate with the Global Programming Lead to implement programming strategies and industry requirements globally - Plan, monitor progress, and address issues related to projects effectively - Provide input on resource plans and budgets for Global Statistical Programming at the product level - Monitor and utilize assigned staff efficiently according to priorities - Lead process improvement initiatives and participate in cross-functional working groups - Assist in study and system audits and inspections - Develop, review, and implement Policies, SOPs, and other controlled documents affecting Global Statistical Programming globally - Provide hands-on support to the assigned product areas - Offer coaching and mentoring to local programming staff - Provide input into career development plans for all staff on assigned projects Qualifications Required: - BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or related field, with at least 8 years of statistical programming experience in a clinical development environment - Strong technical, communication, and leadership skills - Ability to lead and manage programmers effectively for timely completion of programming activities - Experience in developing an offshore statistical programming team - Advanced analysis and reporting skills in SAS, including SAS/STAT, Macro, Graph, SQL, etc. - Previous regulatory submission experience - Proficiency in data quality and compliance checks - Experience in software development and working in a globally dispersed team environment - Staff development leadership and project
