Lead Statistical Programmer

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.