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Senior Manager/Associate Director, Biostatistics - Remote

Company: Precision Medicine Group, LLC.
Location: San Diego
Posted on: April 9, 2021

Job Description:

Office Based : Remote Regular Full-time Business Unit : Clinical Solutions Job Id 7099 Precision for Medicine is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology. We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. The Senior Manager or Associate Director is responsible for leading the biostatistics efforts for specific projects and studies, including reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs. In addition, responsible for managing resources within the Biostatistics and Statistical Programming department. As part of the Biostatistics team, this person will also provide technical expertise to the development of programming standards and procedures. This position is office based for candidates that are located in the Carlsbad, CA area. Candidates that are located elsewhere but are on the Pacific Time Zone can work remotely. Essential functions of the job include but are not limited to:

  • Manage employees, including senior-level, within the Biostatistics and Statistical Programming functional areas
  • Assist with development and maintenance of departmental procedures and standards
  • Assist with project forecasting and resourcing needs through a combination of internal and external resources
  • Hire, train, and provide development opportunities for Biostatisticians and Statistical Programmers
  • Write and/or review statistical analysis plans
  • Provide sample size calculations
  • Provide randomization schedules and serve as the unblinded statistician
  • Program and/or QC CDISC datasets, tables, and figures using SAS
  • Provide input to and/or QC clinical documents, including CRFs, protocols and CSRs
  • Provide oversight for assigned projects
  • Perform the senior level review on a final analysis package delivery of outputs
  • Provide statistical consultative support
  • Assist in creation/review of forms and templates
  • Assist other functional areas as needed Qualifications:
    • Senior Manager: Minimum of 5 years of relevant industry experience
    • Associate Director: Minimum of 7 years of relevant industry experience Other Required:
      • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
      • Experience with SAS
      • Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials Preferred:
        • Experience with oncology and rare diseases If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com . Senior Biostatistician - Remote/Home Based Raleigh - Work from Home, North Carolina US Senior Biostatistician - Remote/Home Based Dallas, Texas US Remote - Statistical Programmer I/ II/Senior - Clinical Trial Services Philadelphia, Pennsylvania US Senior Statistical Programmer I & II - Clinical Trial Services Raleigh - Work from Home, North Carolina US Biostatistician I - Rare Disease Clinical Trials San Diego, California US Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .

Keywords: Precision Medicine Group, LLC., San Diego , Senior Manager/Associate Director, Biostatistics - Remote, Executive , San Diego, California

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