Senior Biostatistician – Fully Remote

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

📋 Description

• Provide expert statistical input for Phase I-IV global clinical trials, which includes designing clinical trials (protocol, sample size, randomization, etc.) and producing and reviewing analysis and reporting deliverables (such as statistical analysis plans) on behalf of and/or in collaboration with Aixial Group clients.

• Create and perform quality control (QC) on study specifications for ADaM datasets, along with statistical programming and QC of ADaM datasets for global Phase I-IV trials.

• Conduct statistical programming and QC of tables, listings, and figures for global Phase I-IV trials.

• Ensure the quality and timeliness of all statistical deliverables.

• As the lead Statistician, take primary responsibility for all statistical activities on assigned studies, including planning and coordinating the activities of assigned statistical team members.

⛳️ Requirements

• A minimum of a Master's (M.Sc.) or equivalent in Medical Statistics, or at least a degree (or equivalent) in Statistics/Mathematics.

• At least 5 years of experience working for a Contract Research Organization (CRO), including 1 to 2 years in a leadership role for studies.

• Proficient in both spoken and written English.

• Excellent skills in SAS programming.

• Experience in project management, specifically regarding timelines and/or budgets related to statistical activities.

• Ability to perform all duties as a project team member independently.

• Capability to execute all responsibilities of a lead team member across several concurrent studies with minimal supervision.

• Computer literacy, ideally in one or more computing systems, programming languages, or software packages in addition to SAS.

• Solid understanding of medical terminology, clinical trial methodology, the drug development process, and ICH/GCP guidelines, particularly as they relate to statistical methodology.

• Good knowledge of statistical principles that underpin clinical trials.

• Familiarity with CDISC requirements.

• Expert knowledge of clinical trial practices, procedures, and methodologies.

• Excellent organizational and time management skills.

• Proficient in developing the statistical section of the study protocol and calculating sample size.

• Experience with Bayesian statistics (BOIN, CRM) is advantageous.

🏝️ Benefits

• Opportunity to join an innovative organization and engage with exciting technologies.

• Access to mentoring and training to enhance your skills in the clinical trials industry.

• Be part of an effective, friendly, and supportive team.

• Competitive employment package.