Statistical Programmer
I
InderoClinical Research
Work remotely anywhere in CanadaFull-TimeMiddle
Salary not disclosed
Apply NowOpens the employer's application page
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
Requirements
- Bachelor’s degree in Statistics, Computing Sciences or a related field (Master’s degree an asset).
- At least 1 year of clinical research experience in biotech, pharma, or CRO industry, including 1 year of statistical programming.
- Exposure to clinical trial data, SAP, TLF Shells, and specifications.
- Excellent working knowledge of SAS (SAS certification an asset).
- Knowledge of CDISC standards and guidelines (CDISC certification an asset).
- Understanding of drug development processes, ICH guidelines, and regulatory requirements.
- Knowledge of XML programming (asset).
- Strong organizational and project planning skills.
- Proven ability to prioritize multiple demands in a high-speed environment.
- Strong verbal and written communication skills in English (French an asset).
Responsibilities
- Develop, maintain, and validate annotated Case Report Forms (aCRFs), specifications, and statistical programming for SDTM, ADaM, and TLFs.
- Support data management with data cleaning activities and resolve statistical data issues.
- Validate SDTMs and ADaMs using Pinnacle 21.
- Review statistical programming scope and budget at trial initiation.
- Use global SAS macros to increase efficiency of statistical programming activities.
- Participate in internal initiatives for the improvement of standards and processes.
- Stay informed on industry standards, CDISC guidelines, and regulatory authority requirements.
View Full Description & ApplyYou'll be redirected to the employer's site
