Principal Statistical Programmer

2 days ago

Remote, India Parexel Full time

**Job Qualifications**:

- Ability to fill Statistical Programming Lead role on projects.
- Input into and negotiate statistical programming timelines.
- Ensure that timelines are adhered to Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
- Monitor project resourcing, project budgets, and identify changes in scope.
- Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
- Review statistical analysis plans and mock-shells.
- Review database set-up specifications.
- Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
- Interact with sponsors and internal stakeholders with regard to statistical programming issues.
- Assist project teams in the resolution of problems encountered and deliver best value and high-quality service.
- Check own work in an ongoing way to ensure first-time quality.
- Use efficient programming techniques to produce/QC derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings.
- Produce/QC dataset specifications and other process supporting documents and submission documentation.
- Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.

**Experience**:

- Strong programming and analytical skills using SAS software.
- Good knowledge and understanding of CDISC SDTM, ADaM and Define.xml standards & TLF’s.
- Proven knowledge of regulatory guidance documents, Proven understanding of clinical trials, fundamentals of clinical research, GCP.
- Strong communication (verbal and written) & interpersonal skills Good team player, self-disciplined & self-motivated with ability to learn faster.

**Education**:

- A Masters in statistics, mathematics, or another relevant discipline. Or B.Sc., Life Science Graduates/ Statistics Graduate/ SAS certified preferable.

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