Principal Statistical Programmer

Join to apply for the Principal Statistical Programmer role at Katalyst CRO
.

• 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, manuscripts, 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 produce documents in collaboration with biostatisticians, data managers, medical writers, etc., and support electronic submission of clinical data to agencies.
• Assist in updating/writing standard operating procedures (SOPs).
• Develop tools in SAS for data analysis and reporting that comply with regulatory requirements.
• Develop specifications such as 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.

• 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 team workloads; 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.

Location:

Durham, NC