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Clinical Data Specialist
2 semanas atrás
We are seeking a skilled Clinical Data Specialist to join our team in the dermatology and rheumatology clinical research field.
The successful candidate will lead multiple clinical trials, developing, maintaining, and validating annotated Case Report Forms (aCRFs), specifications, and statistical programming of SDTM datasets, ADaM datasets, Tables, Listings, and Figures (TLFs), and submission packages.
This role involves reviewing and providing input into Statistical Analysis Plans (SAPs), TLF Shells, and Data Management (DM) documents, supporting data cleaning activities, utilizing global SAS macros, and validating SDTMs, ADaMs, and define.XMLs with Pinnacle 21.
Required Skills and Qualifications- At least 7 years of clinical research experience in biotech, pharma, or CRO, including 5 years in statistical programming and 2 years as a Lead Programmer.
- Strong experience with clinical trial data, SAPs, TLFs, and specifications.
- Proficiency in SAS; SAS certification preferred.
- Familiarity with CDISC standards; CDISC certification preferred.
- Deep understanding of drug development, ICH guidelines, regulations, and electronic data submissions.
- Permanent full-time position.
- Benefits package.
- Ongoing learning and development opportunities.
We are a global leader in dermatology and rheumatology clinical research, with over two decades of experience and a broad international footprint. We provide comprehensive services from protocol design to trial monitoring and biometrics, serving biotech and pharma clients worldwide.
We are committed to diversity and equal opportunity, and we only accept applicants authorized to work in Argentina.