Job Description

• Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects.
• 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.
• Manages timelines for statistical programming activities.
• Assists the Head of Statistical Programming in developing templates for derived dataset specifications, programming specifications, and other supporting documents.
• Develops SAS macros, templates and utilities for reporting and data cleaning.
• Oversees and manages Contract Research Organizations (CROs).
• Develops and tests SAS codes for clinical trial database logic checks.
• Assign tasks to and monitor timelines for junior programmers.

Requirements:

• Bachelor's degree in computer science, Statistics, Mathematics, or a related scientific discipline required.
• Minimum 8 years of experience in statistical programming in a clinical trial environment.
• SAS programming at an expert level.
• Understanding of the drug development process and the functions and roles in a Pharmaceutical/Biotech clinical organization.
• Excellent knowledge of regulatory requirements as related to statistical programming (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.).
• Excellent 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 project manage and assign tasks to other programmers.
• Ability to build successful relationships and interact at the project team level.

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