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Senior Clinical SAS Programmer

Job responsibilities

Responsible for implementation and execution of high quality clinical programming
Demonstrates strong understanding of ICH guidelines, as applicable to clinical programming
Creates programming training exercises, trains new programmers, and serves as mentor
Trains via self-study and self-practice independently and explores advanced topics related to clinical programming and/or drug development
Utilizes System Development Life Cycle (SDLC) for programming deliverables
Interacts directly and independently with client to coordinate all facets of the project; competent communicator
Works with statistical personnel 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 client needs
 Develops clinical programming efficiencies based on broad, in-depth knowledge of procedures
Follows processes related to project management as appropriate for programming projects (e.g. updating Veo Project, updating PSS, close-out procedures etc)
Demonstrates extensive knowledge of departmental processes

Desired Skills and Experience

Work from home option available

At least eight (6-8) years work experience in programming role, preferably supporting clinical trials/ or in the pharmaceutical industry)
Masters in Mathematics, Statistics/ Computer Science of Health Science graduates
Work from home available across India
Advanced knowledge of/ experience with SAS and other relevant programming software
Has high level knowledge of drug development as it pertains to clinical programming; has the ability to apply drug development knowledge during production of high quality programs
Proven experience leading programmer support for multiple clinical trials and submission activities (or equivalent)
Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP. ICH)
Strong experience with data and production of TLGs
Thorough understanding of CDISC standards and HL-7 standards
Experience in pharmaceutical or CRO industry
Proven experience in development of advanced MACROs with high programming efficiency;
Working knowledge of database design/ structures and basic statistics
Working experience in pooling analysis datasets across multiple clinical studies (or equivalent)
Familiarity with ISO 9001:2008 requirements

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