Principal Statistical Programmer

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

📋 Description

• Assume the role of Statistical Programming Lead on various projects

• Contribute to and negotiate statistical programming timelines while ensuring compliance

• Oversee and guide statistical programming teams to complete studies within established timelines and budgets

• Monitor project resources and budgets, identifying any changes in scope

• Facilitate project start-up activities and develop global programs, tracking spreadsheets, and necessary documentation

• Review statistical analysis plans, mock shells, and database setup specifications

• Provide leadership, project-specific training, stakeholder engagement, sponsor support, resource management, and project management for clinical trial programming tasks

• Collaborate with sponsors and internal stakeholders regarding statistical programming challenges

• Assist project teams in resolving daily operational issues

• Generate and ensure quality control of derived datasets, tables, figures, and data listings utilizing efficient programming methods

• Produce and verify dataset specifications, process-supporting documents, and submission materials

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

• Continuously update regulatory knowledge and enhance understanding of SAS and Parexel processes

• Train and mentor team members and project teams; facilitate knowledge-sharing sessions

• Maintain study documentation for traceability and regulatory compliance

• Participate in audits and regulatory inspections as necessary

• Lead or engage in process and quality improvement initiatives

• Offer statistical programming consultancy to both internal and external sponsors

• Represent Parexel at sponsor marketing, technical, and cross-functional meetings and initiatives

• Evaluate technology and processes to enhance quality, efficiency, and productivity

⛳️ Requirements

• Hold a degree in a relevant field and/or possess equivalent professional experience

• Proficient in both written and spoken English

• Exceptional communication skills

• Proven experience in successfully leading teams within a statistical programming environment

• Strong analytical abilities

• Advanced proficiency in SAS programming techniques

• Comprehensive understanding of the programming and reporting processes

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

• Understanding of efficacy endpoints and analysis techniques pertinent to the disease being addressed

• Capability to learn new systems and operate within a dynamic technical landscape

• Strong project management and organizational capabilities

• Ability to juggle competing priorities and adapt to changes

• Proven ability to successfully lead and mentor a global team

• Strong presentation, negotiation, influencing, business awareness, and business development skills

• Client-centric approach to work

• Ability to operate effectively in a quality-focused environment

• Knowledge of CDISC, 21 CFR Part 11, and electronic submissions

🏝️ Benefits

• Comprehensive health and wellness programs

• Opportunities for professional development and growth

• Flexible work arrangements

• Engaging and collaborative work environment