Principal Statistical Programmer

4 days ago

India Parexel Full time

Ability to fill Statistical Programming Lead role on project so Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.

**Responsibilities**:

- 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 in the conduct of their daily work.

**Requirements**:

- Excellent analytical skills.
- Advanced knowledge of SAS programming techniques.
- Extensive knowledge and understanding of the programming and reporting process.
- Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
- Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated.
- Ability to learn new systems and function in an evolving technical environment.
- Strong project management skills.
- Strong organizational skills, ability to manage competing priorities, and flexibility to change.
- Attention to detail.
- Ability to successfully lead and mentor a global team.
- Work effectively in a quality-focused environment.
- Excellent time management in order to meet daily metrics or team objectives.
- Show commitment to and perform consistently high quality work.
- Strong business/operational skills that include customer focus, commitment to quality management, and problem solving.
- Demonstrate commitment to refine quality processes.
- Good presentation skills.
- Ability to negotiate and influence in order to achieve results.
- Good business awareness/business development skills (including financial awareness).
- Client-focused approach to work. Good negotiation skills.

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