Senior Director Biostatistics

Company: Spectum Pharmaceuticals Inc.
Location: Irvine
Posted on: January 13, 2021

Job Description:

Tracking Code 745-470 Job Description Summary:To lead biostatistics functions and activities for one or more therapeutic areas or productsResponsibilities:--Lead the biostatistics function and all biostatistics activities in clinical development and medical affairs. Take active role in supporting clinical trials from strategy, trials, approval and commercial support. Support design of clinical trials, estimate sample sizes, select appropriate statistical methodologies. Support generation of statistical section of study protocols, statistical analysis plans, data review, clinical study reports and regulatory submissions. Perform statistical analysis and analysis QC. Support adhoc analysis required for medical affairs activities, manuscripts, abstracts and regulatory communications. Oversee statistical work performed at CRO's. Ensure compliance with regulatory guidelines. Provide input to CRF design, database development, CSR writing. Oversee statistical deliverables for data monitoring committees.Skills, Education and Experience:--

• Requires MS in statistics or related fields, PhD in statistics or related fields preferred
• 12+ year experience in clinical trials and drug development, preferably oncologic drugs
• Applicants must possess reasonable knowledge related to statistical programming in the pharmaceutical industry, excellent project management abilities, excellent oral and written communications skills, and excellent strategic planning and presentation skills.
• Regular interaction with SAS programmers, Clinical Operations, Data Management, Medical monitors and Project Management. Must be able to handle multiple demands and shifting priorities.--Availability:--
  • Must be available to work in the evenings and weekends, as required.--Position Location and/or Territory and Travel
    • Position located in Cambridge, MA or Irvine, CA and relocation is required.
    • Position will require about 10% travel, as needed.Spectrum Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color. Religion, sex, national origin, disability, veteran status, and other protected characteristics. Job Location Irvine, CA or Cambridge, MA, United States Position Type Full-Time/Regular

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