Biostatistician

Summary This position is responsible for providing statistical input to development strategies, and ensuringeffective implementation, in orderto support product development objectives within one or more therapeutic areas. As a key member of the statistical department, this role will be responsible for biostatistical activities for Gan & Lee projects, including design, analysis, and presentation of data to advance new product development, domestic/international regulatory submissions, and lifecycle management of existing products. This position reports directly to the Senior Director and Head of Biometrics. Education and Experience

• MS in Biostatistics/Statistics/Computer Science/Biology/Pharmacy or related field, PhD ispreferred

• 3-10 years of experience in biostatistics, preferably in clinical research or biotechnology.

• Proven experience managing multiple projects simultaneously.

• Experience in chronic disease is required, diabetes/weight loss programs is a plus.

• Prior experience in regulatory interactions (e.g., FDA, EMA) and submissions is required.

Skills and Qualifications

• Strong expertise in clinical trial design, drug development regulations, and biostatistics.

• Ability to provide technical solutions to a wide range of difficult problems.

• Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.

• Working knowledge of regulatory guidelines and Commercial needs relating to statistical analysis, study reports and statistical components of regulatory submissions.

• Able to manage multiple projects simultaneously, to manage and coordinates limited resources to produce quality deliverables within timelines for competing priorities, and to be flexible when priorities change.

• Highly effective written, oral, and interpersonal communication skills as well as ability to work in interdisciplinary contexts outside statistics.

Responsibilities

• Contributes to the development of study protocols, in particular, the statistical sections (e.g., sample size calculations, statistical methodology and analyses).

• Develops statistical analysis plans and file/report specifications; determine appropriate statistical methodology for data analysis; reviews study setup activities including but not limited to randomization, CRFs and data edits.

• Performs statistical analyses, interprets statistical results, and assists in clinical study reports including integrated summaries for submissions.

• Contributes to development of submissions to worldwide regulatory agencies and preparation of responses to statistical issues arising in regulatory activities or from external development partners.

• Maintains liaison with clinical research personnel in order to identify and provide the statistical support required by the development strategy.

• Participate and representing the company in communicating with health authorities for biostatistical approach

• Ensure compliance with regulatory standards (e.g., GCP, FDA, EMA) and best practices.

• Collaborate with cross-functional teams (e.g., clinical science, clinical operations, data management) to support study objectives.