Senior Statistical Programmer

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🖥 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 budget • Monitor project resourcing and budgets and identify scope changes • Coordinate project start-up activities, global programs, tracking spreadsheets, and required documentation • Review statistical analysis plans, mock-shells, and database set-up specifications • Interact with sponsors and internal stakeholders on 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 in accordance with quality standards, SOPs/Guidelines, ICH-GCP, and regulatory requirements • Maintain and expand regulatory knowledge within the clinical industry • Develop knowledge of SAS and processes within other Parexel functional areas • Provide training and mentorship to staff and project teams • 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 consultancy to internal and external sponsors • Represent Parexel at sponsor marketing and technical meetings • Understand regulatory requirements for CDISC, 21 CFR Part 11, and electronic submissions

🎯 Requirements

• Educated to degree level in a relevant discipline and/or equivalent work experience • Equivalent work experience may substitute for the degree-level education • Competent in written and oral English • Excellent analytical skills • Proficiency in SAS • Extensive knowledge and understanding of the programming and reporting process • Knowledge of SOPs/Guidelines, ICH-GCP, and applicable local and international regulations, including 21 CFR Part 11 • 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 a global team • Effective time management to meet daily metrics or team objectives • Good presentation skills • Good business awareness and business development skills, including financial awareness