16 Jul
Associate Director, Biostatistics (Remote)
Wisconsin, Madison , 53701 Madison USA

Vacancy expired!

This Jobot Job is hosted by: Jamie BeeneAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $190,000 - $250,000 per year

A bit about us:We are a specialty analgesic CRO and site that supports all phases of discovery for novel analgesics. We provide scientific leadership and have extensive experience with the analgesic approval process.

Why join us?Fully Remote Flexible Hours Full Medical, Vision, and Dental 401k + Match

Job DetailsJOB DESCRIPTION:Contributes to initiatives for the structure and development of the Biostatistics department. Responsible for both management and technical aspects of the biostatistics elements of clinical trials. Oversees the direction, planning, execution, and interpretation of the statistical data analysis activities related to clinical trials/research (Phase I-IV), including the support of regulatory submission by provision of CDISC standardized study data and support of regulatory submission by provision of CDISC standardized study data and support of ISS/ISE analyses. Establishes and approves scientific methods for design and implementation of clinical protocols, analysis methods, analysis presentations and final reports.RESPONSIBILITIES:• Responsible for working closely with internal functions, such as Programming, Data Management, Regulatory Affairs, and Project Management.• Responsible for interacting directly with sponsors as part of the study team.• Responsible for the review of and input into the statistical aspects of Clinical Development Materials (Protocols, Regulatory Submissions, CSR etc.) and for providing feedback ot the project team and/or sponsor regarding their review both verbally and in written form.• Responsible for all aspects of statistical analyses of clinical trials data, Phases I-IV, including development of statistical analysis plan and mock shells; creating tables, listings, and graphs; sample size estimation; randomization schedules; and other relevant tools.• Serves as core tam member for projects comprising a program, which includes supervising the initiation, planning, and execution of all statistics related tasks awarded to the department per contract as well as monitoring the operational and financial status of the Biostatistics department's portion of the contract.• Performs QC of any statistical data/outputs received from external vendors/statisticians• Identifies and evaluates fundamental issues for the biostatistics department and other functional areas as relevant.SKILLS and/or ABILITIES• Min 7 years relevant statistical experience in clinical trials is required• M.S in Statistics/Biostatistics required; higher degree preferred• Leadership experience required• Experience in the design, execution and data analysis of clinical studies• SAS and R, NDA and Phase I - Phase IV experience• ICH and Google Cloud Platform experience is required; GMP and GLP preferred• Knowledge of clinical product knowledge in the pharmaceutical industryInterested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Vacancy expired!


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