Head of Biometrics

2 months ago

กรงเทพมหานคร, Thailand JAC Recruitment Full time

Job title:
- Head of Biometrics- Contract type:
- Permanent- Location:
- Bangkok- Specialisation:
- Healthcare & Life Sciences- Reference:
- PR/111147- Contact details:
- Pacita Phaohusara (Pat)- Job published:
- June 06, 2023 17:19Our client is a clinical research organization.

**Responsibilities**:

- Create statistical analysis plans (SAPs) in coordination with cross-functional teams for clinical trials and research.
- Create and implement the statistical technique, including the estimation of the sample size, randomization, and statistical analysis, for the evaluation of clinical trial data.
- To assure the accuracy and integrity of the data, develop and maintain statistical programming codes and carry out quality control checks.
- Create and review presentations, statistical reports, and data summaries for regulatory organizations, study researchers, and other project team members.
- Ensure that statistical analyses are carried out in accordance with regulatory criteria and offer statistical advice and direction to the clinical trial team.
- Use subgroup and exploratory analysis to find potential signals and trends in the data.
- Review the procedures for clinical studies and offer suggestions on statistical issues, such as research design and objectives.
- Ensure data quality, completeness, and correctness by collaborating with the teams in charge of data management and clinical operations.
- Contribute statistical updates and direction at clinical trial and project team meetings.
- Collaborate with the clinical data management team to ensure the validity, accuracy, and completeness of the data.
- Create and put into practice data management strategies, which include database architecture, data cleansing, and data validation.

**Qualifications**- At least five years of experience in biostatistics or statistics, with proof of expertise in the planning, conducting, and reporting of clinical trials.-
- Excellent statistical programming abilities, including proficiency of data processing and visualization (e.g., SAS, R).-
- Comprehensive understanding of regulatory requirements for clinical trial design and reporting (e.g., FDA, EMA).-
- Excellent communication skills, including the capacity to explain statistical ideas and findings to stakeholders from both technical and non-technical backgrounds.-
- Prior leadership or management experience with a group of statisticians is preferred.-
- Effective time management abilities with the capacity to handle several tasks and priorities at once.

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