Medical Writer & Biostatistician Officer is responsible for protocol development, data management, study reporting, and serving as a statistician in clinical studies. This role ensures that all results and data meet high-quality standards in accordance with ISO/IEC 17025, Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) requirements.
- Responsible for searching the study literature prior to develop study protocol.
- Managing the study data from the company activities to be calculated statistically, such as pharmacokinetic parameters and other statistical parameter.
- Performing code breaking of the study in front of the sponsor.
- Responsible for making the final study report.
- Responsible for Ethics Committee & regulatory submission of Clinical Trial.
- Responsible for other additional / special task that assigned by the superior manager.
- Perform Medical monitoring and Pharmacovigilance for Clinical Trial Project.
- Bachelor's degree from Pharmacy (preferably Apothecary graduates)
- At least 1 year experience as the Medical Writer & Biostatistician in Pharmaceutical Companies or Clinical Research Industry
- English proficiency is preferred