Senior Statistical Programmer
I
InderoClinical Research
The successful candidate for this position is given to work remotely anywhere in RomaniaFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 5 years of clinical research experience, 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 biotech, pharma, or CRO industry.
- 4 years of experience in Statistical Programming.
- 1 year of experience acting as a Lead Statistical Programmer.
- Excellent working knowledge of SAS (certification an asset).
- Excellent working knowledge of CDISC standards and guidelines (certification an asset).
- Strong understanding of drug development processes and ICH/FDA/Health Canada regulations.
- Experience with SAP, TLF Shells, and clinical trial data specifications.
- Knowledge of XML programming an asset.
- Strong verbal and written communication skills in English (French an asset).
- Ability to work independently and as part of a team in a fast-paced environment.
Responsibilities
- Act as Lead Statistical Programmer on multiple clinical studies.
- Develop, maintain, and validate aCRFs, SDTM, and ADaM datasets.
- Generate and validate Tables, Listings, and Figures (TLFs) and submission packages.
- Review and provide input into SAPs, TLF Shells, and DM documents.
- Support data management with data cleaning, edit checks, and issue resolution.
- Utilize global SAS macros and Pinnacle 21 to ensure high-quality programming deliverables.
- Collaborate with biostatisticians and project teams to meet timelines and regulatory standards.
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