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Principal Statistical Programmer
Lead SAS and CDISC programming across complex clinical studies at Worldwide Clinical Trials, a global clinical research organization. Oversee regulatory submissions, quality initiatives, and statistical programming teams.
विवरण
- Lead complex studies, including regulatory submissions and integration projects, and take accountability for their delivery.
- Manage sponsor expectations and coordinate with Biostatistical Operations leaders to align resources and meet deadlines.
- Direct large study teams to deliver work on schedule and to quality standards.
- Balance competing priorities and respond to changing needs.
- Lead quality and process improvement initiatives while managing varied project work.
- Apply CDISC standards across multiple studies.
- Improve Biostatistical delivery processes using advanced SAS expertise and alternative technical solutions.
- Advise teams on regulatory submission requirements.
- Guide and develop colleagues across the department.
- Support statistical reporting with table, figure, and listing shells; derived dataset specifications; report documents; and tabulations.
- Maintain programming and validation documentation.
- Develop and maintain internal programming standards.
- Validate software and test SAS macros, keeping validation and testing records.
- Support Quality Assurance activities and audits.
- Follow WCT and sponsor quality systems, GCP standards, and FDA Quality System Regulation requirements, including 21 CFR Part 11.
- Carry out other duties as assigned.
आवश्यकताएँ
- A university degree.
- At least 8 years of relevant experience.
- Advanced SAS programming skills.
- Expertise in SAS/Macro, PROC REPORT, and ODS.
- Working knowledge of SAS/GRAPH, PROC SQL, and SAS/STAT.
- Expert-level hands-on experience in project statistical programming.
- Expertise in CDISC standards, including SDTM, ADaM, Define.xml, and CRT components.
- Expertise in upstream data management and downstream medical writing processes.
- Computer literacy and numeracy.
- Willingness to adapt to different computer systems.
- Compliance with applicable GCP standards and FDA Quality System Regulation, including 21 CFR Part 11.
लाभ
- Equal employment opportunity regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or another class protected by applicable law.
- A diverse and inclusive work environment.
- Supportive, collaborative teams.
- Professional development and leadership opportunities.
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