Biostatistician II
📋 Role Overview & Responsibilities
Responsibilities include:Provides statistical input to clinical development plans (CDP), including study design, sample size, primary and secondary endpoints, and statistical analysis method by working together with clinical pharmacological and other functions.Support protocol development on early phase studies to ensure a clear description of clinical study design, randomization, statistical analysis methodology, and key statistical activities in the protocol.Develop a detailed Statistical Analysis Plan (SAP) to document technical considerations and corresponding mock tables, figures, and listings.Support final tables, figures, and listings development for final study report (CSR), publication, and regulatory submissions.Reviews final statistical tables, listings, and figures.Provides specs to SAS programmers for generating analysis datasets.Produce Randomization codes.Coordinate with data management to Review CRF and IDRP, review and approve database structure, and edit-check specifications.Proactively and timely communication with the study team on stats activities and its progress per planned timeline by working with Clinical management.
Qualifications/Experience:Masters or PhD in Statistics or Biostatistics with a minimum of 3 years of experience in the pharmaceutical industry.
Required Skills:In-depth knowledge of statistical principles, applications, and SAS programming software.Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).Awareness of new drug developments and statistical methodologies in the business.Working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions.
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This position is located in New York, United States with potential relocation and sponsorship assistance depending on candidate qualifications.
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