Senior Statistical Programmer – FSP

October 10

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Parexel

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Healthcare Insurance • Biotechnology • Pharmaceuticals

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.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; • Perform programming validation to ensure quality of analysis datasets and programming outputs. • Provides programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis. • Support the electronic submission preparation and review. • Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; • Assesses impact on programming activities. • Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers. • Provides leadership for ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices. • Identifies opportunities for increased efficiency and consistency within team and our interactions with strategic vendors. • Independently leads and/or performs programming assignments with minimal supervision. • Support improvement initiatives.

🎯 Requirements

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required. • Proficiency in SAS. • Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development. • Demonstrated proficiency in analytical programming. • Have in-depth understanding of clinical data structure (e.g., CDISC standards) and relational database. • Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21. • Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. • Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. • Have good understanding of regulatory, industry, and technology standards and requirements. • Have good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. • Demonstrated ability to work in a team environment with clinical team members.

🏖️ Benefits

• Competitive financial packages • Training and development • Fully flexible work arrangement