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 CFR Title 21, Part 11 regarding electronic records
Strong organizational skills for managing multiple projects
Consistent experience as a lead statistical programmer on multiple projects
Strong understanding of drug development and interdependencies of functions
Proven ability to mentor junior team members
Responsibilities
Convert specifications into SAS code for datasets and output generation
Ensure overall project delivery including clinical trial and regulatory reports
Create statistical analysis outputs for publications and regulatory submissions
Establish and uphold standardized programming procedures
Develop and validate SAS macros for compliance with regulatory standards
Maintain clinical processing workflow systems
Lead project-specific training and manage stakeholder relationships
Benefits
Opportunities for professional development and training
Collaborative working environment
Exposure to high-impact clinical projects and regulatory processes
Strengthening of leadership skills through mentoring opportunities
Engagement with multidisciplinary teams
Full Job Description
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.
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 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.
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.
