Contributes to day-to-day statistical programming activities in support of ongoing projects
Develops SAS outputs as necessary to support data management and clinical review of data
Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards, regulatory requirements, and statistical instructions
Develops and/or validates SAS programs to generate statistical output (e.g. TLFs) of clinical trial data as specified in the Statistical Analysis Plan (SAP), as required for regulatory and safety review reasons (i.e. DSUR or IDMC deliverables), and for ad hoc analysis as requested
Documents data and programming information in accordance with SOPs, guidelines and industry standards
Collaborates with team members to help track timelines for statistical programming activities
Assists in the development and maintenance of derived dataset specifications, programming specifications, and other supporting documents
Develops SAS macros, templates and utilities for reporting and data cleaning
Provides oversight to Contract Research Organizations (CROs)
Develops and tests SAS codes for clinical trial database logic checks
Works closely with senior programmers and statisticians to learn best practices and contribute to team deliverables
Embody core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives
Requirements
Minimum of Bachelor’s Degree; Bachelor’s Degree in Computer Science, Statistics, Mathematics, or a scientific discipline preferred
SAS programming at an intermediate level
Minimum 3 years of experience in statistical programming in a clinical trial environment
Understanding of the drug development process and the functions and roles in a Pharmaceutical/Biotech clinical organization
Strong knowledge of regulatory requirements as related to statistical programming (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.)
Foundational knowledge of concepts related to statistical programming (e.g., coding dictionaries, annual reporting, EDC systems, etc.)
Outstanding verbal and written communication skills
Ability to effectively manage timelines and priorities
Ability to build successful relationships and interact at the study team level
Benefits
market-competitive salaries
an annual bonus program
education assistance
retirement plan with employer match
stock options at all levels
summer hours
professional development resources and access to development resources to help you grow personally and professionally
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