Principal Statistical Programmer

5 months ago

Remote, India Parexel Full time

**Key Accountabilities**:
**Project Management**:

- 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 in the conduct of their daily work.

**Statistical Programming for Assigned Projects**:

- 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.

**Training**:

- Maintain and expand local and international regulatory knowledge within the clinical industry.
- Develop knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other PAREXEL functional areas.
- Provide relevant training and mentorship to staff and project teams.
- Lead knowledge sharing forums and proactively support the development of the wider department.

**General**:

- Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
- Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
- Proactively participate in and/or lead process/quality improvement initiatives.
- Provide consultancy to internal and external sponsors with regard to statistical programming tasks.
- Represent PAREXEL at sponsor marketing and technical meetings.
- Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity.
- Represent Statistical Programming on cross-functional technical initiatives.
- Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).

**Skills**:

- 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.

**Knowledge and Experience**:

- Competent in written and oral English.
- Excellent communication skills.
- Proven record of successfully leading teams in a statistical programming environment.

**Education**:

- Educated to degree level in a relevant discipline and/or equivalent work experience.

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