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Manager, Biostatistics

Company: ClinDatrix, Inc.
Location: Irvine
Posted on: April 4, 2021

Job Description:

The Experience of Big. The Advantage of Value. ClinDatrix is looking to hire a full time in-house--Manager, Biostatistics. The ideal candidate should be located in Southern CA and work in the ClinDatrix office. ClinDatrix is a small service provider, CRO, located in Irvine, CA dedicated to clinical research, data management, and statistical analyses and reporting servicing the biotechnology, medical device, and pharmaceutical industries. Responsibilities

  • Manage Biostatistics staff and statistical programmers as appropriate, including but not limited to resource planning, recruitment, performance evaluations, and training.
  • Coordinate and oversee statistical analyses and programming activities on clinical trials.
  • Facilitate interaction and communication between Biostatistics and other members of the project teams to which s/he is assigned (Clinical, Data Entry, Medical Writing, Data Management, Safety, Project Management, etc.).
  • Represent the Sponsor, when required, in discussions and meetings with the FDA.
  • Develop study-specific Statistical Analysis Plans based upon the protocol, clinical monitoring plan and Case Report Forms (CRFs) to ensure that the data collected during clinical trials are analyzed using appropriate analyses and are reported to a level appropriate to meet regulatory requirements.
  • Manage the implementation of all Statistical Analysis Plans with the statistical programmers.
  • Develop and maintain statistical/programming policies, guidelines, and procedures (SOPs, training manuals, etc.).
  • Review protocols for Biostatistics input.
  • Perform Sample Size and Power Calculations.
  • Conduct statistical analyses and perform SAS programming, as needed.
  • Prepare randomizations for clinical trials.
  • Write statistical reports and review integrated clinical/statistical reports.
  • Review IND/NDA submissions.
  • Provide statistical consulting and education to others within ClinDatrix, Inc. and to sponsors.
  • Maintain complete and auditable documentation of all statistical/programming activities.
  • Provide other general duties as required to support the company. Qualifications and Requirements
    • PhD in Statistics with five or more years experience as a clinical statistician; or a Masters Degree in Statistics with eight or more years experience as a clinical statistician.
    • One year of supervisory experience including project management, resource planning, staff recruitment, performance evaluations, career development, and training.
    • Knowledge of FDA regulations respecting data quality and clinical trials conduct, analyses, and reporting.
    • Strong written and oral communication skills. Proven leadership skills. Ability to work within a team environment. Ability to manage competing priorities in a changeable environment. Ability to handle stressful situations and deadlines. Excellent interpersonal skills. To start the conversation, please write, fax or click--here . Primary Sidebar Contact Us Take advantage of our value and experience.
      ClinDatrix, Inc. * 1 Ada, Suite 250 * Irvine, CA 92618 * Tel: 949.428.6600 * Fax: 949.428.1239

Keywords: ClinDatrix, Inc., Irvine , Manager, Biostatistics, Executive , Irvine, California

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