Lead Clinical Biostatistician - SAS & CDISC Expert

Worldwide Clinical Trials; Poland; On-site; PLN 210,000 - 270,000; Full time

Job summary

Worldwide Clinical Trials in Poland is seeking an experienced Senior Statistician to join our Biostatistics team. You will provide statistical leadership on projects, review study designs, analysis plans and reports, and develop SAS programs for analysis of clinical study data.

The role requires strong knowledge of SAS, CDISC standards, and regulatory requirements (ICH/FDA). You will collaborate with sponsors, data managers, statisticians, and the wider study team across multiple therapeutic

Qualifications

• Must be computer literate and numerate with a proven ability to adapt to various computer systems; thorough knowledge of SAS; knowledge of other software applications a plus.
• Consultancy and facilitation skills are required together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating, and influencing, embracing innovation and change.
• Hands-on expert level project statistician experienced in providing statistical leadership to projects.
• Experienced in a broad range of statistical applications across all phases of clinical research with a thorough knowledge of regulatory standards and exposure to regulatory interactions.
• Good oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English.
• Ability to prioritize and handle multiple projects simultaneously, a flexible approach, the ability to use sound independent judgement and take initiative to assess information.
• Experience across multiple therapeutic areas.

Responsibilities

• Provide review of study designs, analysis plans, and reports. Contribute to the design of clinical trials, including statistical sections of the study protocol, randomization methodology and writing Statistical Analysis Plans.
• Provide support to the statistics reporting process through the specification/review of tables, figures, and listing shells, writing/review of derived dataset specifications, and the formatting of report documents and tabulations.
• Undertake and/or contribute to the preparation of final reports, including production of tables, figures, and listings and report writing.
• Develop, test, and run SAS programs for the statistical analysis of clinical study data. This includes programs for derived datasets, SDTM/ADaM datasets, tables, figures, and listings, and/or associated validation.
• Contribute to the identification of system and process improvements, and to the development and implementation of solutions to improve the efficiency and quality of clinical study data processing and reporting.
• Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met by expert and timely statistical consultancy and support.

Skills

SAS

Statistical programming

Clinical trials

Regulatory knowledge

English communication

Education

BSc/8 years

MSc/6 years

PhD/4 years

Tools

SAS

Job description

Worldwide Clinical Trials in Poland is seeking an experienced Senior Statistician to join our Biostatistics team. You will provide statistical leadership on projects, review study designs, analysis plans and reports, and develop SAS programs for analysis of clinical study data.

The role requires strong knowledge of SAS, CDISC standards, and regulatory requirements (ICH/FDA). You will collaborate with sponsors, data managers, statisticians, and the wider study team across multiple therapeutic