GSP Senior Manager - CDISC Consultancy Group Head

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.

Amgen Global Statistical Programming Department (GSP) is seeking a Biostatistical Programming Senior Manager to lead the CDISC Consultancy Group. This Senior Manager will be accountable and responsible for defining SDTM strategy for GSP and providing technical expertise and programming leadership to ensure highg quality SDTM project deliveries.

Purpose:

• Provide SDTM technical expertise and programming leadership to ensure project deliveries
• Define SDTM strategy for GSP
• Provides advice and consultation to senior management and cross-functional teams

Role Description:

• Strategy refinement and execution
• Oversee the advisory body that consults with product teams for SDTM implementation of clinical trial data
• Oversee the SDTM consulting needs for GSP
• Reports to Clinical Programming and CDISC Implementation Head

Responsible for:

• Overseeing the process for the review of study start up documents such as Protocol, CRF, DARS, and other supporting documents
• Overseeing the process for the review SDTM datasets and related documents for analysis and regulatory submissions

Key Project Responsibilities:

• Provide strategic leadership and oversight to teams that develop compliant and consistent CDISC SDTM datasets, define files and reviewer's guides on time with high quality
• Promote, adhere to and comment on global and functional standards, processes and methods across all products and studies
• Oversee and cross-functionally coordinate CDISC SDTM standards and Amgen SDTM Controlled Terminology
• Oversee the process for the regular run and disposition of published conformance checks for all snapshots and SDTM audit for all pivotal snapshots
• Support global standards content management (e.g., SDTM specifications, metadata, SDTM-IG versions)
• Support cross-functional development of global, TA, and/or product-level CRFs
• Manage Amgen SDTM knowledge base
• Provide CDISC/SDTM training to GSP
• Involvement with CDISC Community
• Assist in study and system audits by internal and external bodies, and provide guidance for responses to audit questions and findings

Key Management Responsibilities:

• Manage CDISC Consultancy Group resources according to priorities. Efficiently and effectively monitor and utilize CDISC Consultants
• Match CDISC Consultant abilities to tasks
• Provide leadership on SDTM needs for each product
• Provide input on the development and review of GDO and CFDA Policies, SOPs and other controlled documents that impact the SDTM process
• Sponsor continuous improvement in the SDTM process within GSP and cross-functionally as applicable
• Provide input into and help facilitate career development plans for CDISC Consultants

Decision Making Authority

• Leads and manages projects and accountable for all deliverables
• Develops strategies and drives solutions impacting projects
• Independent judgment and decision making
• Provides input to area leadership

Basic Qualifications:

• BA/BSc or higher degree in quantitative or scientific subjects
• At least 8 years of relevant statistical programming experience, or equivalent clinical data standards experience, in a clinical development environment
• Experience working effectively in a globally dispersed team environment with cross-cultural partners
• Excellent oral and written English communication skills
• Good negotiation skills
• Prior staff development leadership and project management experience
• In-depth experience creating/working with annotations on blank CRF.pdf, reviewers guide, published conformance checks and controlled terminology
• In-depth experience in project management to enable deliverables to be done on time and to a high quality
• Working experience with clinical trial data

Preferred Qualifications:

• MSc or higher degree in quantitative or scientific subjects
• Thorough understanding of TA (e.g. oncology, respiratory) standards
• Ability to train others
• Prior leadership and/or management experience
• Working experience with external Functional Service Providers (FSP)

Knowledge:

• Thought leadership
• Thorough understanding of drug development processes and clinical trial life cycle
• Working knowledge of latest CDISC SDTM IG and define standards. Basic knowledge of CDISC standards of CDASH, SEND, and ADaM

Competencies:

• Problem solving
• Team work
• Attention to detail
• Scientific and technical excellence
• Oral and written communication
• Project management
• Leadership
• Innovation

Join Us

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

Amgen provides a comprehensive Total Rewards Program designed to enhance the long term financial, physical, and overall well-being of our staff and their families. We offer competitive compensation, long term incentive opportunities, generous paid time off, 401k, medical, dental and vision just to name a few.

As an organization dedicated to improving the quality of life for people around the world, Amgen champions 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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.