5-7 years of experience in statistical programming, particularly using SAS
Expertise in SAS/BASE, SAS/STAT, with additional knowledge of SAS/CONNECT, SAS/ACCESS, SAS/MACRO, and SQL
Familiarity with clinical data standards including SDTM and ADaM
Understanding of FDA and ICH regulations, specifically CFR Title 21, Part 11
Proven track record as a lead programmer on multiple concurrent projects
Strong analytical skills with the ability to navigate complex unstructured data
Excellent leadership and mentoring abilities.
Responsibilities
Convert specifications into SAS code for datasets and regulatory outputs
Oversee project delivery for clinical trial reports and submissions
Generate statistical analysis outputs for clinical publications and reports
Establish standardized programming procedures and work instructions
Develop macros and programs to ensure compliance with regulatory standards
Maintain clinical processing workflow systems
Provide project management and stakeholder engagement for programming tasks.
Benefits
Collaborative work environment promoting professional growth
Opportunities for mentorship and leadership development
Access to ongoing training and resources for professional advancement
Support for obtaining certifications and additional qualifications
Engagement in innovative projects with a focus on regulatory compliance.
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 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.
