Senior Statistical Programmer – FSP

November 22

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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

• Provide technical expertise for the conduct of clinical trials. • Act as an internal subject matter expert in specific areas providing technical support and expert advice. • Work independently to support various programming activities related to the analysis and reporting of clinical study data. • 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. • Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis. • Support the electronic submission preparation and review. • Review key planning documents (e.g., statistical analysis plan, data presentation plan) for alignment with development team objectives. • Interact with vendors regarding project standards and programming specifications. • Provide leadership for ensuring quality of deliverables by applying standards and complying with regulatory requirements. • Identify opportunities for increased efficiency within the team and interactions with strategic vendors. • Independently lead and/or perform 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. • In-depth understanding of clinical data structure (e.g., CDISC standards) and relational database. • Skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21. • Ability in handling and processing upstream data, e.g., multiple data forms, workflow, eDC, SDTM. • Ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. • Good understanding of regulatory, industry, and technology standards and requirements. • Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. • Ability to work in a team environment with clinical team members.

🏖️ Benefits

• Fully flexible work arrangement • Competitive financial packages • Training and development opportunities • Healthy work/life balance