Senior Statistical Programmer – FSP

🔥 3 hours ago

🇿🇦 South Africa – 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

• Provide technical expertise for the conduct of clinical trials • Act as an internal subject matter expert, providing technical support and expert advice • Work independently on programming activities related to clinical study data analysis and reporting • 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 and create 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 • Use efficient programming techniques to produce and QC derived datasets, including SDTM and ADaM/TLF, tables, figures, and data listings • Produce and QC dataset specifications, process-supporting documents, and submission documentation • Ensure QC of derived datasets, tables, listings, and figures complies with corporate quality standards, SOPs/guidelines, ICH-GCP, and international regulatory requirements

🎯 Requirements

• Proficiency in SAS • Minimum 3 years of clinical/statistical programming experience within pharmaceutical clinical development • Experience handling and processing upstream data, including multiple data forms, workflow, eDC, and SDTM • Experience producing outputs for downstream requirements, including ADaM, Data Definition Table, and e-submission • Proficiency in analytical programming • Excellent analytical skills • In-depth understanding of clinical data structures, including CDISC standards, and relational databases • Proficiency with MS Office, XML, and Pinnacle 21 • Ability to work in a team environment with clinical team members • Strong project management skills • Good business awareness and business development skills, including financial awareness • Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences required • Competent written and oral English • Must be authorized to work in South Africa • Employment visa sponsorship is unavailable

🏖️ Benefits

• Competitive financial packages • Training and development • Fully flexible work arrangement • Fully home based work option • Office access for employees who live close to the office • Healthy work/life balance • Employee welfare support