Senior Statistical Programmer (FSP), Georgia, Poland, Serbia, Hungary

About the role

The Senior Statistical Programmer at Parexel is responsible for conducting clinical trials, acting as a subject matter expert, and supporting various programming activities related to the analysis and reporting of clinical study data.

Responsibilities

• 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;
• Support project teams by developing programming strategies, standards, specifications, and programmed analysis;
• Support the electronic submission preparation and review;
• Review key planning documents to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements;
• Assess the impact on programming activities;
• Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers;
• Lead and perform programming assignments with minimal supervision;
• Support improvement initiatives.

Requirements

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required;
• Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development;
• Proficiency in SAS is required;
• Experience with R would be a strong asset;
• In-depth understanding of clinical data structure (e.g., CDISC standards) and relational database;
• Demonstrated ability in 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;
• Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21;
• Good understanding of regulatory, industry, and technology standards and requirements;
• Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.

Qualifications

Applicants must be authorized to work in Georgia, Poland, Serbia, or Hungary.

Skills

• SAS proficiency;
• R proficiency (a strong asset);
• Understanding of clinical data structure (CDISC standards);
• Handling and processing of upstream data;
• Providing outputs to meet downstream requirements;
• Using software tools and applications;
• Regulatory, industry, and technology standards and requirements;
• Statistical terminology, clinical tests, medical terminology, and protocol designs.

Pay

Competitive financial packages offered.

Schedule

Flexible work arrangements available, including remote work options.