Description
We are seeking a Senior Statistical Programmer to review datasets in submission-ready standard format (ADaM), tables, figures, listings, and submission packages. As a Senior Statistical Programmer, you will provide expertise in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for all requested analyses.
Main Responsibilities and Accountabilities: Collaborate with study teams to design data structures and specifications for ad hoc and study deliverables, including ADaM datasets, tables, figures, listings, and analysis submission content. Ensure the quality and accuracy of clinical data as required by authorities (i.e., SDTM, ADaM, tables, figures, listings, define.xml). Lead and oversee requested efforts for pooled and exploratory analyses, working closely with Statistics TA leads and/or study statisticians, as well as with clinical programming teams and their collection of legacy data.
Lead and oversee the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures, and listings) when not provided by CRO. Design and implement complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format. Develop global tools that increase the efficiency and capacity of the Statistical Programming group. Work closely with clinical study teams to plan and execute activities to ensure project timelines are met with high-quality deliverables.
Additional tasks:
- Collaborate with CR&D staff regarding data analysis requests.
- Perform additional statistical analyses, including support responses to regulatory agencies, generating integrated summaries of safety and efficacy, supporting publications and presentations, and supporting planning and reporting of clinical trials via exploratory analyses of available data.
Position Qualifications and Experience Requirements:
- BSc in Computer Science, Mathematics, Statistics, or a related area with relevant experience.
- At least 5+ years of experience in clinical programming and/or statistical programming within the CRO/pharmaceutical environment.
- In-depth understanding of clinical programming and/or statistical programming processes and standards.
- Extensive experience with statistical programming using SAS software, including development and use of SAS Macros.
- Strong programming and problem-solving skills.
- Good experience in R Programming is mandatory for this role (hands-on experience).
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
- Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent).
- Proven ability to work effectively both independently and in a team setting, and to meet set goals by managing own timelines.
- Experience working in cross-functional, multicultural, and international clinical trial teams.