Biometric Specialist

The biggest opportunity in the first research organization by Thai startups. Clinixir looking for outstanding candidates to be a part in building and driving CRO to grow globally.

Overall Responsibilities

• Collaborate effectively with cross-functional teams, including biostatisticians, clinical research associates, data management, and statistical programming personnel, to support study protocol development and ensure datasets are analysis-ready in compliance with applicable standards and regulations.
• Provide statistical input to electronic data capture (EDC) systems, including case report form (CRF) development, review of data validation specifications, and participation in user acceptance testing (UAT) activities, under supervision.
• Participate in study team meetings and contribute to discussions on statistical, data-related, and analysis-related topics under the guidance of senior biostatistical staff.
• Assist in the development, review, and implementation of Statistical Analysis Plans (SAPs) and Table, Listings, and Figures (TLFs) for clinical studies.
• Work closely with Statistical Programmers to support the development, review, and validation of analysis datasets and outputs.
• Review statistical outputs for accuracy, consistency, and compliance with SAPs and reporting standards.
• Contribute to the preparation of statistical reports, summaries, tables, figures, and visualizations for internal review and regulatory submissions.
• Conduct exploratory data analysis and descriptive statistics to gain insights into the data.
• Contribute to the execution of statistical analyses, including hypothesis testing, regression analyses, and time-to-event analyses, according to approved SAPs.
• Support the interpretation of statistical results and contribute to study conclusions under appropriate supervision.
• Ensure data quality and adherence to regulatory requirements by conducting data reviews, audits, and

reconciliations.

• Contribute to the development and maintenance of biostatistics SOPs, templates, and guidelines to ensure consistency and standardization.
• Assist in the identification and implementation of process improvements to enhance data quality and operational efficiency.
• Communicate effectively with internal stakeholders, ensuring clarity and accuracy of information exchange.

Qualifications:

• Bachelor's degree in a relevant scientific discipline, such as Biostatistics, Statistics, or a related field. (required).
• Master's degree in Statistics, Biostatistics / Applied Statistics (preferred).
• Minimum of 1 year of related experience in clinical data management, and statistical analysis within healthcare, clinical research, or pharmaceutical/CRO environments.
• Strong understanding of clinical research processes, regulations, and industry standards (e.g., ICH-GCP) is preferred.
• Proficiency in statistical software (e.g., Stata, SAS, R) and familiarity with data capture or data management systems (e.g., Viedoc, Oracle Inform).
• Excellent analytical and problem-solving skills, with a keen attention to detail.
• Solid understanding of statistical concepts and methods, including hypothesis testing, regression, and survival analysis.
• Strong communication skills, both written and verbal, to effectively collaborate with multidisciplinary teams and present findings.
• Familiarity with CDISC concepts (SDTM/ ADaM) is an advantage.
• Ability to work effectively in a team-based, matrix organizational environment.
• Demonstrated willingness to learn, accept feedback, and develop technical and professional expertise.

Good Benefit

• Annual Leave 15 Days

• Birthday leave 1 Day

• Medical Insurance

-Provident Fund

-Annual health check with flu vaccination

Hybrid Work

Clinixir Office, 173/18 Asia Centre Building (BTS Chongnonsi)