Job Directory Sr. Statistical Programmer Analyst

Sr. Statistical Programmer Analyst
San Francisco, CA

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Job Description

Provide expertise and hands on support to clinical projects across multiple therapeutics areas. Successfully achieves all programming objectives through planning, project management and technical skills.

Responsible for processing of clinical data required for analysis of clinical trials for Phase 1-4. Lead studies and representing statistical programming in cross-functional teams.

Develop SAS coding and table templates for preparing, processing and analyzing clinical data. Generate and QC summary tables, data listings and graphs for in-house analyses of study data or publications using SAS standard coding practices. Create/review programming plan, specifications for datasets and TLFs. Familiar with CDISC conventions, i.e., SDTM and ADaM models and hands on experience implementing these models. Support data queries from other functional group (Medical Writing, Clinical Development, Clinical Operations, Regulatory, Marketing). Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. Proactively applies professional concepts to contribute to development of company's concepts and principles and to achieve objectives in creative and effective way. Acts independently to determine methods and procedures on new assignments. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Manage CRO regarding programming issues and activities to ensure timely delivery of tables and data listings. Validate work of other programmer/analysts at CRO or in-house. Provide guidelines, review, and QC CRO deliverables to ensure the quality of deliverables. Create/acquire tools to improve programming efficiency or quality. Maintaining current knowledge of programming practices and development within the industry. Contribute in development and implementation of programming standards and conventions.

A minimum of a Bachelor's degree in Computer Science, Mathematics, Statistics, and related areas is required. Equivalent experience may be accepted. A minimum 5 years relevant career experience in the pharmaceutical or biotechnology industry. Experience in Oncology and or CNS therapeutic areas preferred. Experience in NDA/BLA submission and understanding of regulatory requirements preferred. Very good knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment in particular clinical trial data setting.

Strong understanding of clinical trial data and hands on in data manipulations, analysis and reporting of analysis results. Track record of generating new ideas and solutions to data analysis. Thorough understanding of relational database components and theory. Excellent oral and written communication skills.

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