Senior Statistical Programmer

This is a fully remote position, open to applicants in India.

📋 Description

• Serve as the Statistical Programming Lead for various projects.

• Contribute to and negotiate timelines for statistical programming, ensuring compliance.

• Organize and guide statistical programming teams to complete studies within set timelines and budget constraints.

• Oversee project resources and budgets, identifying any changes in scope.

• Manage project initiation activities, global programs, tracking spreadsheets, and necessary documentation.

• Evaluate statistical analysis plans, mock-shells, and specifications for database setup.

• Engage with sponsors and internal stakeholders regarding statistical programming concerns.

• Support project teams in resolving day-to-day operational challenges.

• Generate and perform quality control on derived datasets, tables, figures, and data listings utilizing effective programming techniques.

• Create and ensure quality control of dataset specifications, process-supporting documents, and submission materials.

• Guarantee quality control of processes and technical activities in compliance with quality standards, SOPs/Guidelines, ICH-GCP, and regulatory requirements.

• Continuously enhance regulatory knowledge within the clinical sector.

• Acquire knowledge of SAS and processes across other Parexel functional areas.

• Offer training and mentorship to staff and project teams.

• Keep study documentation for traceability and adherence to regulatory compliance.

• Participate in audits and regulatory inspections as required.

• Lead or engage in initiatives aimed at process and quality improvement.

• Provide consultancy services to both internal and external sponsors.

• Represent Parexel at sponsor marketing and technical meetings.

• Understand the regulatory requirements for CDISC, 21 CFR Part 11, and electronic submissions.

⛳️ Requirements

• Possess a degree in a relevant field and/or equivalent work experience.

• Equivalent work experience may be accepted in lieu of degree-level education.

• Proficient in both written and spoken English.

• Strong analytical abilities.

• Expertise in SAS.

• Extensive knowledge and comprehension of the programming and reporting process.

• Familiarity with SOPs/Guidelines, ICH-GCP, and relevant local and international regulations, including 21 CFR Part 11.

• Capability to learn new systems and adapt in a dynamic technical environment.

• Strong project management and organizational capabilities.

• Ability to manage competing priorities and adapt to changes effectively.

• Proven ability to successfully lead a global team.

• Effective time management skills to achieve daily metrics or team objectives.

• Strong presentation skills.

• Good business acumen and business development skills, including financial awareness.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements.

• Supportive and collaborative work environment.