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Senior Statistical Programmer II

Vertex Pharmaceuticals Inc (US)

This is a Full-time position in Boston, MA posted April 6, 2021.

Job Description

The Senior / Principal Statistical Programmer will be responsible for providing hands-on support and technical guidance on clinical project teams. This individual will participate in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. This individual will participate in departmental and cross functional technology development and process improvement initiatives. Key Responsibilities: * Effectively designs and codes SAS programs for assigned clinical projects(s), consistently meeting objectives of the study * Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDlSC SDTM format * Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards * Performs quality control checks of advanced SAS code and output produced by other Statistical Programmers * Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e. g. , macros or graphical user interface applications) * Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry * Manages project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives * May conduct briefings and participates in technical meetings for internal and external representatives (e. g. , IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA) on assigned projects * Performs tasks with minimal instruction from supervisor Minimum Qualifications: * B. S. in Biostatistics, Statistics or Computer Science * 3+ years of experience w/SAS in the pharmaceutical industry Preferred Qualifications: * Masters Degree or PhD in Biostatistics, Statistics or Computer Science * 3+ years of experience w/SAS in the pharmaceutical industry * Proven record of effective and successful project management tasks and skills * Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH * Demonstrates advanced knowledge of electronic submissions and CDlSC * Displays highly advanced knowledge regarding software validation and system development life cycle concepts * Communicates effectively in verbal presentations and written technical reports to both internal and external customers