Purpose:
· Provide advanced technical expertise to develop and maintain programs/methodology to meet internal and external clientele needs.
· Plan and lead the development of project-related solutions to the full scope of statistical programming tasks.
· Provide technical expertise to the Statistical Programming department.
Roles and Responsibilities:
· Design or write program specifications based on consultations with Biostats
· Write SAS codes to produce CDISC complaint datasets.
· Create statistical analysis outputs to be used in support of final reports, abstracts, posters, manuscripts, adhocs and other clinical publications.
· Write QC SAS programs for Dataset, Tables, Listings, and Figures following the departmental QC procedures and good programming practices.
· Write programs for ISS, ISE and pooled datasets.
· Revise programs for corrections, enhancements, or system environment changes.
· Generate Pinnacle 21 reports, Define XML, Define PDFs, and Reviewers Guides. Review Pinnacle 21 report for action needed to fix errors and warnings.
· Assist in establishing standardized programming procedures and work instructions.
· Develop, enhance, evaluate, and validate standardized macros and utility programs.
· Ensure that regulatory requirements are met through validation/compliance activities.
· Use and promote use of established standards, SOP and best practices.
· Other responsibilities as assigned.
Required Knowledge, Skills and Abilities:
· Knowledge of statistics, programming and/or clinical drug development process
· In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
· Ability to implement programming specifications, as appropriate
· Ability to estimate programming scope of work and assist in communicating project status
· Working knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
· Exhibits routine and occasionally complex problem-solving skills
· Recognizes when negotiating skills are needed and seeks assistance.
· Good organizational, interpersonal, leadership and communication skills
· Ability to effectively handle multiple tasks and projects, under supervision
· Excellent accuracy and attention to detail
· Ability to establish and maintain effective working relationships with co-workers, managers, and clients
Minimum Education and Experience:
· Masters degree in computer science, statistics or related field; Bachelor's degree in computer science, statistics or equivalent combination of education, training and experience.
· SAS certification preferred but not required.
· R programming knowledge preferred but not required.
· Strong knowledge of CDISC SDTM and ADaM standards.
· Good understanding of GCP regulatory requirements and drug development process.
· Excellent organizational skills and good verbal and written communication skills.
· Ability to work independently.
Lead Statistical Programmer • kadapa, India
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