Biostatistical Programming Senior Manager

Amgen•South San Francisco, CA

10d•$157,897 - $213,625

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.

Requirements

Doctorate degree and 2 years Statistical Programming experience OR Master’s degree and 6 years Statistical Programming experience OR Bachelor’s degree and 8 years Statistical Programming experience OR Associate’s degree and 10 years Statistical Programming experience OR High school diploma and 12 years Statistical Programming experience
MSc or higher degree in quantitative, software engineering, or scientific subjects
8+ years of relevant statistical programming experience in a clinical development environment
Familiarity with drug development life cycle and experience in analysis of clinical trials data
Solid understanding of the latest CDISC SDTM, ADaM, and Define-XML standards
Expertise with at least one of the following programming languages (SAS, R, Python) and preferably proficiency/expertise with a second programming language (SAS, R, Python, Perl, Java, Javascript, SQL)
Experience with advanced programming capabilities (machine learning, databricks, AI for application development/code generation)
Experience with systems and application programming architectures and platforms including cloud computing, automation, ETL, and other technologies
Excellent oral and written communication skills
Prior staff development leadership and project management experience

Responsibilities

Responsible for the development and maintenance of departmental software utilities to support the analysis and reporting of clinical trial data for GSP.
Maintain and develop re-usable software utilities for GBS and GSP.
Provide technical leadership and guidance for programming teams.
Oversee FSP programming team. Provide guidance and support to ensure their operational success.
Partner with IS to maintain and enhance GSP systems and ensure that they are meeting the needs of statistical programming.
Coordinate and collaborate with CfDA on design and implementation of statistical analysis and reporting applications.
Develop and maintain departmental software utilities to support the analysis and reporting of clinical trials data.
Adhere to functional standards, processes and methods across all projects.
Create, maintain, and review key SDLC documents -Requirements, Operational Qualification, Installation Qualification, and Design documents.
Create, maintain, and review end-user documentation (e.g., user guides, training materials).
Participate in establishing the programming scope, timeline and quality for deliverables with stakeholders.
Participate in the selection of appropriate technologies and software development tools based on GSP priorities and budget.
Make and ensure the implementation of high level strategic decisions, including GSP strategy for adopting newer programming (R, Python, and other).
Designated team leader responsible for project efficiency, timeliness and quality.
Manage resource according to priorities. Match programmer abilities to tasks. Efficiently and optimally monitor and utilize assigned staff.
Provide technical leadership and guidance for programming team.
Lead all programming-related activities on one or multiple concurrent projects.
Leads and manages projects and accountable for all deliverables.
Coordinate and monitor project issue reporting and resolution.
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 input into and help facilitate career development plans for all staff on assigned projects.
Provide mentorship to staff.