Principal Biostatistician

This is a fully remote position, open to applicants in Czechia.

📋 Description

• Responsible for all duties assigned within a clinical study, which may include acting as the study lead for multiple studies, clinical programs, and/or large and complex studies, overseeing all biostatistics-related activities.

• Assist in the review and development of clinical programs; may contribute to complex methodologies and analytical sections of protocols, as well as support design reviews; able to offer feedback on issues or improvements to initially proposed designs.

• May include oversight of statistical programming activities.

• Ensure that all work is completed in a timely manner.

• Guarantee that all created or reviewed content is appropriate, valid, relevant to the study, and of high quality.

• Provide review and oversight of statistical outputs generated by other members of the biostatistics department.

• Review protocols, synopses, and other statistical documents related to a study, offering feedback and consultation.

• Conduct research or provide support for trial design and consultative activities.

• Evaluate relevant content from other functional areas (e.g., Case Report Forms) on behalf of the biostatistics team.

• Draft summaries of findings and results to be included in study reports, such as interim analyses or the final Clinical Study Report (CSR).

• Write or review some or all of the Statistical Analysis Plan and corresponding output shells.

• Provide relevant specifications and guidance for complex and/or pivotal outputs.

• Collaborate with other study team members (both internal and external) to represent the needs and inputs of the statistical components of the study.

• Review outputs (TLFs, SDTM and ADaM datasets, SDTM and ADaM specifications) developed by statistical programmers and/or other statisticians for quality, validity, and appropriateness.

• Offer mentoring and support to junior statisticians.

• Represent the function in internal and external meetings for assigned studies.

• Represent the function during audits of study activities.

• Represent the function in bid defenses and other sales-related activities.

⛳️ Requirements

• Master’s degree (or higher) in biostatistics, statistics, mathematics, or related disciplines.

• General understanding and application of biostatistics in clinical trials.

• Strong relevant experience working in a Contract Research Organization.

• Proficiency in one or more statistical programming languages (SAS and R preferred).

🏝️ Benefits

• Training and career development opportunities within the organization.

• Strong emphasis on personal and professional growth.

• Friendly and supportive working environment.

• Opportunity to collaborate with colleagues from around the globe, with English as the company's primary language.