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
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 obesityprogramming 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 world data, claims, and EMR databases.
Key activities 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)
We are all different, yet we all use our unique contributions to serve patients. The Biostatistical Programming Senior Managerwe seek is a proffesional with these qualifications.
Doctorate degree and 2 years of experience
OR
Master’s degree and 4 years of experience
OR
Bachelor’s degree and 6 years ofexperience
OR
Associate’s degree and 10 years ofexperience
OR
High school diploma / GED and 12 years of experience
Preferred Qualifications
Bachelor’s or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject
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
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include: