Director Biostatistical Programming - Statistical Programming Technology & Support

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

The Director Biostatistical Programming Statistical Programming Technology & Support Head will provide strategy and leadership for Statistical Programming technology, platforms, innovation investments and capabilities. Aligns priorities with IS, GDO functions, CfDA, and other data sciences functions. Develop the strategies to realization utilizing the modern technologies and data sciences approaches enabling modern programming capabilities and automation.

Responsibilities:

• Leader responsible for the development, architecture, technology & operations, and innovations on the platforms, tools, and automations to drive statistical programming deliverables & capabilities
• Provide strategy in platforms, and ensure future capabilities including automation, RPA, and machine learning opportunities to drive efficiencies and services
• Designated team leader responsible for project prioritization and deliver at portfolio level
• Provide technical leadership and guidance for application programming & support team
• Accountable for quality and system compliance for GSP systems, platforms, and services
• Promote standard and consistent strategy and approaches to statistical programming
• Provide input in the development and review of GSP SOPs and other controlled documents
• Provide consistent and ongoing leadership in staff career development
• Manage staff performance and oversee staff assignments and utilization for the TA
• Work cross-functionally to establish and maintain priorities on projects impacting GSP
• Recruit and develop departmental staff

Basic Qualifications:

Doctorate degree and 4 years of relevant statistical programming/systems engineering/application programming experience in a clinical development or life sciences setting

OR

Master's degree and 8 years of relevant statistical programming/systems engineering/application programming experience in a clinical development or life sciences setting

OR

Bachelor's degree and 10 years of relevant statistical programming/systems engineering/application programming experience in a clinical development or life sciences setting

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• MSc or higher degree in quantitative or scientific subjects
• 10+ years of relevant statistical programming or Software Development experience in a clinical development environment supporting statistical programming
• Clinical programming technologies knowledge for data collection, curation, and analysis (SAS, R, Python, RAVE, other technologies)
• Experienced leader with systems architecture, platform technologies including ASP, Cloud, and other technologies
• Experience working effectively in a globally dispersed team environment with cross-cultural partners
• Excellent oral and written English communication skills
• Strong negotiation skills
• Prior staff development leadership and project management experience
• In-Depth experience in project management to enable deliverables done on time and to a high quality
• Working experience with clinical trial data
• Working experience in submissions, ad-hoc tasks, and complex data mappings
• Working experience with external Functional Service Providers (FSP) or CRO
• Experience of data sciences, automation, and artificial intelligence in support of stat programming activities
• Thorough understanding of TA (e.g. oncology, general medicine, etc) standards
• Expertise with other programming languages (e.g. Python, Java, R, or S-Plus)
• Working experience with external staffing providers
• Ability to train others

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.