- Provide subject matter expertise in designing and developing clinical trials, protocols, and case report forms.
- Offer technical support and expert advice to internal and external sponsors.
- Lead and influence ongoing clinical studies by supporting statistical and non-statistical analyses.
- Implement programming and project standards in accordance with the Statistical Analysis Plan.
- Act as a liaison between clinical management, subcommittees, and project teams.
- Use efficient programming techniques to produce and quality-check derived datasets, tables, figures, and data listings.
- Convert program specifications into SAS code for datasets and outputs.
- Lead overall project delivery, including clinical trial reports and regulatory submission deliverables.
- Create statistical analysis outputs for final reports, abstracts, posters, manuscripts, and other clinical publications.
- Assist in establishing standardized programming procedures and work instructions.
- Develop, evaluate, and validate standardized macros and utility programs.
- Assist in developing client proposal documents.
- Provide leadership, project management, and resource management for programming tasks supporting clinical trial activities.
- Provide input into statistical programming timelines and negotiate timelines.
- Mentor statistical programmers and provide input into documents produced by other functions.
- Keep updated on statistical programming techniques and technical advancements.
- Interact with regulatory agencies regarding electronic submission specifications.
- Monitor project resourcing, budgets, and scope changes.
- Ensure the quality, traceability, and timeliness of programming deliverables.
- Participate in process/quality improvement initiatives.
- Provide consultancy to internal and external sponsors on statistical programming tasks.
- Ensure compliance with relevant regulatory requirements.
- Bachelor's degree in Computer Science, Mathematics, Statistics, Life Sciences, or related field.
- Minimum of 6 years of experience using SAS in clinical trials data analyses.
- Exposure to CDISC (SDTM and ADaM) is a plus.
- Expertise in SAS/BASE, SAS/STAT, 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.
- Strong organizational and time management skills.
- Consistent experience as a lead statistical programmer.
- Excellent analytical and presentation skills.
- Proven ability to learn new systems and function in an evolving technical environment.
- Ability to negotiate, influence, and create strategies to improve efficiency.
- Business awareness and financial acumen.
- Ability to work effectively in a quality-focused environment.
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Senior SAS Programmer - Cambridge, United States - IntePros
Description
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