1. Reads and analyzes protocol, statistical analysis plan, CRF and other trial design documents and discusses with other team members such with as biostatisticians and data managers.
2. Develops and debugs simple to complex SAS program in a timely manner
3. Implements statistical analysis plan, data preparation, and data manipulation into SAS programs and macros
4. Create analysis datasets, statistical tables, figures, and listing for clinical trial data.
5. Create CDISC standard datasets (SDTM and ADaM)
6. Participates in the validation of SAS programs and analysis datasets
7. Maintains documentation for SAS programs and validation results
8. Leads and coordinates the programming work for projects involving SAS programming if necessary
9. Coordinates timelines in orders to fulfill the needs of other departments
1. Design CRF based on study protocol and prepare the CRF completion guideline.
2. Generate data management plan and data validation plan.
3. Clinical Data Management / Clinical data management status report.
4. Provide training to the site personnel and reporting agencies on proper data collection processes.
5. Coordinate with clinical monitoring activities to help provide prompt feedback to sites on data quality.
6. Establish data quality standards and works with reporting agencies to ensure standards are met.
7. Generate and close queries or apply self evident corrections to the data according to the relevant guidelines.
We are seeking a Clinical Operations Coordinator to oversee the planning and execution of clinical studies in compliance with GCP/ICH guidelines and company SOPs. This role serves as the primary contact for clinical trial operations and manages day-to-day activities to ensure successful study completion.
1.. Study Oversight & Compliance
- Lead planning, execution, and management of clinical studies.
- Ensure compliance with GCP/ICH guidelines, applicable regulations, and company SOPs.
- Act as the primary point of contact for all clinical trial operational activities.
2.. Team Leadership & Coordination
- Manage day-to-day activities of the clinical operations team.
- Provide guidance and oversight to ensure timelines, budgets, resources, and quality standards are met.
3.. Cross-Functional Collaboration
- Work closely with clinical project managers, medical monitors, pharmacokinetics, data management, regulatory affairs, and pharmacovigilance teams.
- Ensure efficient and effective study conduct through cross-functional alignment.
4.. Stakeholder Communication
- Communicate study progress to internal and external stakeholders.
- Identify and mitigate study risks and issues proactively.
5.. Site & Vendor Management
- Oversee investigational sites and third-party vendors to ensure high-quality execution.
6.. Documentation & Systems
- Ensure clinical project-related documents and systems are developed and maintained to high standards.
1. Assist in performing project proposal tasks including drafting budget quotations.
2. Perform administrative management processes, including business document/ file archiving and management, payment processing, and project closure.
3.Meeting coordination and arrangements, assist in project database integration and update project-related master lists.
4. Assist in participating in biotech/medical-related exhibitions and marketing activities, collect and compile client information and conduct periodic client visits.
5. Provide business projects support and perform other tasks assigned by Supervisors.
6. SOP revised and updated by BD director's instruction.
We are seeking a highly skilled Website & Digital Content Specialist to join our pharmaceutical company in Taiwan. This role will be responsible for managing, updating, and optimizing our global website content, ensuring accuracy, compliance, and timely execution of updates. The ideal candidate will have strong experience in biopharma or life sciences content management, excellent English proficiency, and the ability to serve as a key liaison with cross-functional teams, including our U.S. headquarters, medical/legal/regulatory (MLR) review boards, and brand planning committees.
This position goes beyond execution: the selected candidate will also contribute strategic insights on how to improve website engagement, align digital content with brand strategy, and enhance our global online presence.
<Key Responsibilities>
1.Website Content Management
• Own the process of updating and maintaining company website content (corporate, product, medical education, and brand-related pages).
• Ensure scientific and medical accuracy of all published content, with special attention to regulatory compliance.
• Coordinate urgent or time-sensitive content updates, ensuring flawless execution under tight timelines.
2.Cross-Functional Collaboration
• Act as the key owner and liaison for Medical-Legal-Regulatory (MLR) review processes, ensuring all digital content passes required approvals.
• Work closely with U.S. and Asia-based teams, bridging time zones and cultural contexts to ensure seamless communication.
• Participate in brand planning discussions, contributing recommendations on content strategy and alignment with brand goals.
3. Digital Strategy & Social Media
• Support and enhance the company’s digital presence across owned media (website, social media, corporate communications).
• Leverage social media management experience to recommend content strategies and community engagement initiatives.
• Monitor digital content performance and propose optimization opportunities.
1. Review/write the statistical part and study design of protocol
2. Review/write SAP/SAR
3. Statistical analysis result consulting
4. Statistical part in CSR writing
5. Apply advanced study design (ie. adaptive design, Bayesian method, dose selection based on model)
6. Sample size estimated consulting
7. Statistical simulation in sample size estimation
8. Support of Business Development
9. Provide training in statistical analysis to internal or clients.