Statistical Expert

Gan & Lee Pharmaceuticals seeks an experienced Statistical Expert to lead biostatistical activities in support of product development objectives.

• The successful candidate will provide statistical input to development strategies and ensure effective implementation within one or more therapeutic areas.

1. Contribute to the development of study protocols, focusing on statistical sections such as sample size calculations, statistical methodology, and analyses.
2. Develop statistical analysis plans, file/report specifications, and determine appropriate statistical methodologies for data analysis. Review study setup activities including randomization, CRFs, and data edits.
3. Perform statistical analyses, interpret results, and assist in clinical study reports, including integrated summaries for submissions.
4. Support the development of submissions to worldwide regulatory agencies and prepare responses to statistical issues arising in regulatory activities or from external partners.
5. Maintain liaison with clinical research personnel to identify and provide statistical support required by the development strategy under the direction of the clinical leader.
6. Represent the company in communicating with health authorities for biostatistical approach.
7. Develop and implement data management strategies for clinical trials and research studies.
8. Lead the data management team, fostering collaboration and ensuring adherence to timelines and quality standards.
9. Oversee the design, development, and validation of data collection tools (e.g., CRFs, eCRFs) and databases.
10. Ensure compliance with regulatory standards (e.g., GCP, FDA, EMA) and best practices.
11. Collaborate with cross-functional teams to support study objectives.
12. Serve as the point of contact for data management-related inquiries and audits.
13. Monitor data entry, cleaning, and validation processes to ensure accuracy and completeness.
14. Establish and maintain SOPs for data management activities.
15. Provide training to internal teams and external partners on biostats processes and requirements.

To be considered for this role, you should have:

• A strong background in biostatistics and experience working in a pharmaceutical industry setting.
• Excellent communication and leadership skills, with the ability to work effectively across departments.
• Strong analytical and problem-solving skills, with the ability to interpret complex data sets.
• Experience with data management systems and software, such as CRMs and RDBMS.
• Familiarity with regulatory standards and guidelines, including GCP, FDA, and EMA.

The salary for this role is $120,000 - $150,000 per year, depending on experience. In addition to a competitive salary, we offer a range of benefits, including:

• Health insurance
• Retirement plan
• Professional development opportunities
• Tuition reimbursement
• Flexible work arrangements

We are committed to creating a diverse and inclusive work environment that supports the growth and development of our employees. If you are a motivated and experienced professional looking for a challenging opportunity, please submit your application today