We have a need for a Sr. Biostatistician.
• Keep abreast with advanced statistical analysis methods and results/data presentation formats of clinical data.
• Collaborates with Medical Monitor, Clinical Research Associate (CRA), Medical Writer, Clinical Data Management (CDM), and Statistical Programmer in developing a clinical study protocol, case report forms (CRFs), and edit checks.
• Provides a sample size based on the specification provided by Medical Monitor.
• Develops a statistical analysis plan for a clinical study or publication.
• Develops analysis specifications for Statistical Programmer and reviews/verifies analyses and programming codes for quality assurance.
• Participates in development of standard reporting programs for clinical studies.
• Participates in development of standard CRFs for clinical data collection.
• Participates in regulatory submissions including CSR, IND safety update, Annual Report/PSUR, and integrated summaries of safety and efficacy in NDA and BLA Ensures the quality of data and accuracy of analyses in regulatory submissions (e.g., CSR) or publications.
• Develops SOPs, guidelines, and template.
The candidates should meet following requirements:
(1) MS degree in Statistics or closely related field, PhD preferred and
(2) 5 years of industry experience, oncology experience preferred.
• Experience with writing/reviewing statistical analysis plans, working on study protocol, study design, and ad hoc analysis
• Possesses strong SAS programming skills
• In-depth knowledge of clinical development including clinical operations, data management, and clinical study report preparation workflow
• North American or European regulatory experience and in-depth knowledge of FDA/EU regulations and guidelines
• Must be knowledgeable of statistical methods in clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS), and regulatory regulations/guidelines.
Preferred to have worked on electronic NDA and/or BLA submissions via e-CTD.
• Excellent oral and written communication skills
• Ability to work on cross-functional teams is crucial
• Works well on a project team and possesses flexibility
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