Senior Biostatistician – Biostatistics

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

📋 Description

• Provide expert statistical input for Phase I-IV global clinical trials, encompassing the design of clinical trials (protocol, sample size, randomization, etc.) and the creation and review of analysis and reporting deliverables (including statistical analysis plans) on behalf of and/or in collaboration with clients of Aixial Group.

• Develop and ensure quality control of study specifications for ADaM datasets, along with statistical programming and quality assurance of ADaM datasets for global Phase I-IV trials.

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

• Ensure the quality and timely delivery of statistical outputs.

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

⛳️ Requirements

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

• At least 5 years of experience working with a CRO, including 1 to 2 years in a leadership role for studies.

• Proficient in both spoken and written English.

• Exceptional SAS programming skills.

• Experience in managing project timelines and/or budgets related to statistical activities.

• Capability to perform all responsibilities as a project team member without supervision.

• Ability to execute all duties of lead team member across multiple concurrent studies with minimal oversight.

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

• Strong oral and written communication skills, including the ability to convey statistical concepts and information to non-statisticians.

• Solid understanding of medical terminology, clinical trial methodology, drug development processes, and ICH/GCP (particularly regarding statistical methodology).

• Good grasp of statistical principles underpinning clinical trials.

• Familiarity with CDISC requirements.

• In-depth knowledge of clinical trial practices, procedures, and methodologies.

• Excellent organizational and time management skills.

• Experience in developing the statistical section of study protocols and calculating sample sizes.

• Familiarity with Bayesian statistics (BOIN, CRM) is an advantage.

🏝️ Benefits

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

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

• The chance to be part of a dynamic, friendly, and supportive team.

• Competitive employment package.