Principal Statistical Programmer - Katalyst Healthcares & Life Sciences

Responsibilities: Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs
Be responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables
Create statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts and other clinical publications; support systems to produce electronic regulatory submissions
Assist in establishing standardized programming procedures and work instructions
Develop, enhance, evaluate, and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation/compliance activities
Develop and maintain clinical processing workflow systems
Assist in the development of client proposal documents
Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities
Provide input into and negotiate statistical programming timelines
Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets
Trained in sponsor SOPs and disseminate knowledge to project team members as appropriate
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) records handling (e.g., Chapter 21 of the US Code of Federal Regulation – Part 11), and electronic submission of clinical data to agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards) Assist in updating/writing PROMETRIKA standard operating procedures (SOPs) Develop tools in SAS for data analysis and reporting that comply with regulatory requirements
Develop specifications (e.g., metadata files), annotate CRFs and create SAS programs for the mapping of raw datasets to CDISC SDTM standards
Create define.xml files from metadata files for SDTM and ADaM Convert data received in other formats to SAS datasets
Requirements: Must have expertise in SAS/BASE, SAS/STAT, and knowledge of SAS/CONNECT, SAS/ACCESS, SAS/MACRO, SAS/GRAPH, SQL, and ODS Knowledge of SDTM, ADaM, FDA and ICH guidance Understanding of Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems
Good organizational skills across individual projects and managing own and teamwork loads
Ability to organize, manage and complete multiple assignments with challenging timelines independently and effectively
Consistent experience as a lead statistical programmer on several concurrent projects Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions Strong mentoring skills as shown by leadership of projects and if applicable, junior team members
Excellent analytical skills Proven ability to learn new systems and function in an evolving technical environment
Ability to negotiate and influence to achieve results
Good presentation skills Good business awareness/business development skills (including financial awareness) Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial
Work effectively in a quality-focused environment
Knowledge of other programming languages and database management software packages is a plus.