Biostatistical Programming Senior Manager

Amgen • Salt Lake, VA

8d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Biostatistical Programming Senior Manager What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for programming activities supporting the obesity therapeutic area.  This individual will report to the Director of General Medicine - Obesity programming in CfOR’s Data & Analytic Center. The senior manager provides leadership to the obesity programming team in the development and execution of real-world evidence (RWE) observational studies and ensures adequate and timely delivery of results. The individual is responsible for oversight of the US programming team and planning, organizing, and managing resources to ensure high quality and timely delivery of observational research programming deliverables. The senior manager leads and contributes to efforts to identify, develop and implement departmental standards, applications, processes , and training. This position requires management of a technical team and a comprehensive understanding of statistical programming languages and platforms, real wor l d data, claims , and EMR databases. Key a ctivities include: Lead, manage , and develop programming staff Provide technical solutions to programming problems within CfOR Lead and develop technical programming and process improvement initiatives within CfOR Represent the programming function and participate in multidisciplinary project team meetings Project 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 and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications Write, test, validate and execute department-, product- and protocol-level macros and utilities Oversee the work of outsourced resources assigned to project Review Requests for Proposals (RFPs) from outsourcing vendors for programming services 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 )

Requirements

• Doctorate degree and 2 years of experience OR Master’s degree and 4 years of experience OR Bachelor’s degree and 6 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience
• For therapeutic area support, ten (10) years clinical research and development programming and managing experience
• For system and process support, ten (10) years project management, software application development and managing experience
• Drug Development (pre-, early, late and/or observational) in related industries or academic research)
• Project planning and management
• Process improvement leadership
• Participation in the development of policies and SOPs
• International co-operation
• Computer programming, preferably SAS or other procedural languages
• Understanding of computer operating systems, UNIX preferred
• Biostatistical Programming within Drug Development
• Drug Development Process & Operations
• Software development & design

Nice To Haves

• Bachelor’s or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject

Responsibilities

• Lead, manage, and develop programming staff
• Provide technical solutions to programming problems within CfOR
• Lead and develop technical programming and process improvement initiatives within CfOR
• Represent the programming function and participate in multidisciplinary project team meetings
• Project 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 and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
• Write, test, validate and execute department-, product- and protocol-level macros and utilities
• Oversee the work of outsourced resources assigned to project
• Review Requests for Proposals (RFPs) from outsourcing vendors for programming services
• 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)

Benefits

• A 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, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed