Job Description

12 month renewable (potential contract to hire after 12 months)- Onsite San Diego with a very promising pharma client Description Responsible for collaborating with statisticians and data managers on the statistical programming strategy for multiple clinical studies. Serves as primary in-house programmer on multiple studies. Participates in the development of programming strategy for clinical studies, case report forms, database design, data management plans, programming specifications and statistical analysis plans. Responsible for production and quality control of tables, listings, figures, analysis datasets. Develops strategy for documentation of quality control of datasets and statistical analysis outputs. Responsibilities:

• Function as lead programmer in the development and quality control of tables, listings, figures, analysis datasets, and/or systems in support of analyses utilizing current industry standards including CDISC SDTM and ADaM
• Provide programming input to Case Report Form development, Statistical Analysis Plans, analysis file specifications, and tables, figures, and listings shells
• Provide programming support for the preparation of integrated reports, submissions and post-submission activities
• Provide programming support for complex presentations and more complex statistical ad hoc requests
• Act as primary programming representative on cross-functional study teams to ensure timely and quality support for required analyses
• Work with management team to determine resource requirements for therapeutic area or department function responsibilities
• Monitor progress of and provide oversight of CROs working on sponsored studies
• May supervise and/or mentor other programmers (internal and contract)
• Maintain project files that ensure adequate and clear documentation of statistical analyses and quality control
• Play a key role in meeting cross-functional goals through commitment, quality standards, and a customer service orientation
• Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration

• BS/BA degree or equivalent in a relevant scientific discipline; medical or mathematics/computer science background a plus
• Minimum 8 years of prior experience as a Statistical Programmer using SAS
• Supervisory experience a plus; Experience managing programmers preferred
• Good communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers and medical writers
• In-depth knowledge of FDA/ICH guidelines and industry/technology standard practices
• Detailed knowledge and experience in clinical study design, CRF design, central laboratories, programming databases, query resolution, data validation
• Good understanding of clinical data and pharmaceutical development
• Demonstrated proficiency in using SAS to produce derived analysis datasets and produce TFLs
• Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats
• Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM
• Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission
• Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
• Ability to manage multiple and diverse issues

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