Job Description
Summary This position is responsible for providing statistical input to development strategies, and ensuring effective implementation, in order to 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 is preferred
- 3-10 years of experience in biostatistics, preferably in clinical research or biotechnology.
- Proven experience managing multiple projects simultaneously.
- Experience in diabetes/weight loss programs is preferred.
- 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.
Job Tags
Full time, Worldwide, Flexible hours,