- 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.
- ssist 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.
- ssist 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)
- ssist 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 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 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.
- bility to negotiate and influence to achieve results.
- Good presentation skills
- Good business awareness/business development skills (including financial awareness)
- bility 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.
Principal Statistical Programmer - Hanscom Air Force Base, United States - Katalyst Healthcares and Life Sciences
