Provide expertise and hands on support to clinical projects across multiple therapeutics areas. Lead technology or process initiative. Lead the design or development of global utilities and macros.
Responsible for processing of clinical data required for analysis of clinical trials for Phase 1-4.
* Lead studies or compounds 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. Review CRF, edit check, data transfer specification and related documents. Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. Support data queries from other functional groups (Medical Writing, Clinical Development, Clinical Operations, Regulatory, and Marketing). Provides guidance on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables. Proactively applies professional concepts to contribute to development of company's concepts and principles and to achieve objectives in creative and effective way. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments.
Perform vendor qualifications. Manage CRO regarding programming issues and activities to ensure timely delivery of tables and data listings. Provide guidelines, review, and QC CRO deliverables to ensure the quality of deliverables. Validate work of other programmer/analysts at CRO or in-house. Create/acquire tools to improve programming efficiency or quality. Participate in the task forces and new initiatives, while maintaining current knowledge of programming practices and development within the industry. Collaborate with Head of Statistical Programming to develop, implement and maintain SOPs and working practices for Standard directory structure and contents. Be a major Contributor to activities in statistical systems development, validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools. Contribute in Building Statistical Programming Infrastructure. Contribute in development and implementation of programming standards and conventions. Work with other functional groups to identify areas where statistical programming support can enhance efficiency and quality.
A minimum of a Bachelor's degree in Computer Science, Mathematics, Statistics, and related areas is required. A Masters or PhD is preferred. Equivalent experience may be accepted.
A minimum 8 years relevant career experience in the pharmaceutical or biotechnology industry. Excellent knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment in particular clinical trial data setting. Very good knowledge with CDISC conventions, i.e., SDTM and ADaM models and hands on experience implementing these models. Experience in Oncology and or CNS therapeutic areas preferred. Experience in NDA/BLA submission and understanding of regulatory requirements preferred.
Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results. Track record of generating new ideas and solutions to data analysis. Excellent application development skills. Excellent oral and written communication skills.
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