Key skills
CloudETLJavaJavaScriptPerlPythonSDLCSQLRAIMachine LearningDatabricksStatistical AnalysisLeadershipProject ManagementCommunication
About this role
Role Overview
- 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
- 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 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
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
Tech Stack
- Cloud
- ETL
- Java
- JavaScript
- Perl
- Python
- SDLC
- SQL
Benefits
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits