Principal Biostatistician

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

📋 Description

• Serve as the lead for multiple studies, clinical programs, and/or large and complex studies, overseeing all biostatistics-related tasks.

• Assist in the review and creation of clinical programs, contributing to intricate methods and analysis sections of protocols while providing feedback on design issues or potential enhancements.

• May entail overseeing statistical programming efforts.

• Ensure timely execution of all tasks.

• Guarantee that all generated or reviewed content is suitable, valid, relevant to the study, and maintains high quality standards.

• Offer review and oversight of statistical outputs produced by other members of the biostatistics team.

• Evaluate protocols, synopses, and other statistical documents related to a study, providing feedback and consultation.

• Conduct research or support trial design and consultative initiatives.

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

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

• Write or review some, or all, sections of the Statistical Analysis Plan and corresponding output templates.

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

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

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

• Mentor and support junior statisticians.

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

• Act as a representative for the function during audits of study activities.

• Participate in bid defenses and other sales-related initiatives.

⛳️ Requirements

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

• General understanding and application of biostatistics in clinical trials.

• Significant experience working within a Contract Research Organization.

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

🏝️ Benefits

• Internal training and career development opportunities.

• Strong focus on personal and professional growth.

• Friendly and supportive work environment.

• Opportunity to collaborate with colleagues globally, with English as the company’s primary language.