Statistical Programmer
I
InderoClinical Research
Work remotely anywhere in RomaniaFull-TimeJunior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 1 year of clinical research experience in biotechnology, pharmaceutical or CRO industry, including 1 year of Statistical Programming
- Required Skills
- Data management
Requirements
- Bachelor’s degree in Statistics, Computing Sciences or a related field (Master’s degree an asset).
- Minimum 1 year of clinical research experience in biotech, pharma, or CRO industry.
- Minimum 1 year of experience in Statistical Programming.
- Significant exposure to clinical trial data, SAP, and TLF Shells.
- Excellent working knowledge of SAS (SAS certification an asset).
- Knowledge of CDISC standards and guidelines (CDISC certification an asset).
- Knowledge of drug development process, ICH guidelines (E6, E9, E9(R1)), and FDA/Health Canada regulations.
- Strong organizational, project planning, and time management skills.
- Ability to work independently and collaboratively in a high-speed environment.
- Strong verbal and written communication skills in English.
- Knowledge of XML programming is an asset.
- French language proficiency is an asset.
Responsibilities
- Develop, maintain, and validate annotated Case Report Forms (aCRFs) and statistical programming of SDTM, ADaM, and TLFs.
- Support Data Management with data cleaning activities including reporting and closing statistical data issues.
- Validate SDTMs, ADaMs, and define.XML files using Pinnacle 21.
- Utilize global SAS macros to improve the efficiency and quality of programming activities.
- Review statistical programming scope and budget during clinical trial initiation.
- Develop and validate SDTM define.XML/PDF and ADaM Reviewer’s Guides.
- Participate in internal initiatives to develop or improve standard macros and programming processes.
- Maintain knowledge of latest industry, CDISC, ICH, and regulatory standards.
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