Senior Statistical Programmer
I
InderoClinical Research, CRO
The successful candidate for this position is given to work remotely anywhere in Argentina.Full-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 5 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry, including 4 years of Statistical Programming and 1 year acting as a Lead Statistical Programmer.
Requirements
- Bachelor’s degree in Statistics, Computing Sciences or a related field (Master’s an asset).
- At least 5 years of clinical research experience in biotechnology, pharmaceutical or CRO industry.
- Minimum 4 years of Statistical Programming experience.
- Minimum 1 year of experience acting as a Lead Statistical Programmer.
- Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications.
- Excellent working knowledge of SAS (certification an asset).
- Excellent working knowledge of CDISC standards and guidelines (certification an asset).
- Knowledge of XML programming an asset.
- Excellent knowledge of drug development process, ICH guidelines, and FDA/Health Canada regulations.
- Strong verbal and written communication skills in English (French an asset).
Responsibilities
- Lead single and multiple clinical trials, ensuring deliverables are produced within timelines and budget.
- Develop, maintain, and validate aCRFs, SDTM datasets, ADaM datasets, and TLFs.
- Review and provide input into Statistical Analysis Plans (SAPs), TLF shells, and data management documents.
- Support data management with cleaning activities by programming, reporting, and reviewing data issues.
- Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21.
- Use global SAS macros and participate in internal initiatives to increase efficiency.
- Act as Unblinded Primary or QC Statistical Programmer for randomization plans, lists, IDMCs, and IAs.
- Mentor junior Statistical Programmers.
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