Senior Statistical Programmer

Job Description

We are recruiting for an experienced Senior Statistical Programmer who is hands-on and can lead projects. We are looking for a motivated self-starter with existing clinical programming experience who is looking for a fresh challenge. This position is remote.Roles & Responsibilities
• Confidently displays excellent internal and external customer service
• Responsible for implementation and execution of high quality clinical programming
• Demonstrates strong understanding of ICH guidelines, as applicable to clinical programming
• Creates and presents programming training exercises, trains new programmers, and serves as mentor
• Utilizes System Development Life Cycle (SDLC) for programming deliverables
• Trains via self-study and self-practice independently and explores advanced topics related to programming and/or drug development
• Interacts directly and independently with client to coordinate all facets of the project; highly competent communicator with excellent client interaction skills
• Provides high level of support to the statisticians and medical writers on all programming matters according to client requirements
• Works with statisticians to provide definitions, documentation and review of derived variables needed to produce planned tables, listings, and graphs
• Generates tables, listings, and graphs from clinical trial databases using SAS
• Develops programs, verifies, validates, and maintains clinical trial databases and data entry screen using SAS and related software
• Develops data and programming specifications jointly with other programmers and biostatisticians
• Designs specific data presentations including creative summary tables, graphs, and patient listings
• Assists with preparing data validation plan based on customer needs
• Reviews data management guidelines for computer edit/validation checks
• Independently implements and validates QC findings in compliance with the NC Handling Procedure
• Conducts thorough self-reviews of deliverables prior to release to client; serves as high level reviewer for others
• Follows processes related to project management as appropriate for programming projects (e.g. updating VeoProject, updating PSS, close-out procedures etc)
• Demonstrates extensive knowledge of departmental processes (e.g. competency in programming software and willingness to share information)
• Takes initiative to suggest and implement programming process improvements and follows through to completion
• Leads most projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the client
• Demonstrates excellent internal and external leadership skills for projects
• Fully accountable for providing highest quality deliverables of entire project to satisfy or exceed client requirements
• May produce and present external company presentations providing industry visibility for the organization
• Accountable for timelines, as well as, internal team interactions
• Complies with Document Control Procedure
• Complies with Record Control Procedure
• Ensures compliance to applicable ISMS policies and procedures
Job Requirements (Minimum Education / Experience / Training / Skills)
• Preferably a minimum of 6 years experience in the Clinical Research/Statistical Programming Environment
• College graduate in computer science or related field, or related experience
• Has high level knowledge of drug development as it pertains to programming; has the ability to apply drug development knowledge during production of high quality programs
• Extensive hands-on experience with clinical trials and pharmaceutical development
• Strong experience with data and production of TLGs
• Strong programming and logic skills
• Thorough understanding of CDISC standards and HL-7 standards
• Extensive experience in pharmaceutical or CRO industry preferred
• Strong SAS programming, SAS Base, SAS Macro experience
• Thorough knowledge of clinical database structures
• Ability to program data presentations, using program such as SAS procedures
• Subject matter expert for SAS programming skills; willing to guide others in a variety of programming techniques
• Strong proficiency with MS Office applications
• Excellent organizational and communication skills
• Strong familiarity with ISO 9001:2000 requirements
Please assume that your application was unsuccessful if we dont make contact within 14 days of your submission. ,

Keyskills :
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