Principal Statistical Programmer

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🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Fill the Statistical Programming Lead role on projects • Input into and negotiate statistical programming timelines and ensure adherence • Coordinate and lead statistical programming teams to complete studies within timelines and budgets • Monitor project resourcing and budgets and identify scope changes • Coordinate project start-up activities and create global programs, tracking spreadsheets, and required documentation • Review statistical analysis plans, mock-shells, and database set-up specifications • Provide leadership, project-specific training, stakeholder management, sponsor support, resource management, and project management for clinical trial programming tasks • Interact with sponsors and internal stakeholders regarding statistical programming issues • Assist project teams in resolving daily-work problems • Produce and QC derived datasets, tables, figures, and data listings using efficient programming techniques • Produce and QC dataset specifications, process-supporting documents, and submission documentation • Ensure QC of process and technical activities according to quality standards, SOPs/Guidelines, ICH-GCP, and regulatory requirements • Maintain and expand regulatory knowledge and develop knowledge of SAS and Parexel processes • Train and mentor staff and project teams; lead knowledge-sharing forums • Maintain study documentation for traceability and regulatory compliance • Participate in audits and regulatory inspections as required • Lead or participate in process and quality improvement initiatives • Provide statistical programming consultancy to internal and external sponsors • Represent Parexel at sponsor marketing, technical, and cross-functional meetings and initiatives • Assess technology and processes to improve quality, efficiency, and productivity

🎯 Requirements

• Educated to degree level in a relevant discipline and/or equivalent work experience • Competent in written and oral English • Excellent communication skills • Proven record of successfully leading teams in a statistical programming environment • 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 applicable local and international regulations such as 21 CFR Part 11 • Knowledge of 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 and organizational skills • Ability to manage competing priorities and adapt to change • Ability to successfully lead and mentor a global team • Good presentation, negotiation, influencing, business awareness, and business development skills • Client-focused approach to work • Ability to work effectively in a quality-focused environment • Understanding of CDISC, 21 CFR Part 11, and electronic submissions