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Palo Alto, California Apex Systems
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Title: Biostatistician Lead

Duration: 6 month contract, likelihood to extend

Location: Palo Alto

The Biostatistician Lead assumes responsibilities for all statistical aspects of development project including study designs, planning and execution of statistical analyses, coordination and management of other study statisticians and CROs. The Biostatistician Lead will also provide any statistical contributions necessary for clinical development programs including regulatory interactions. This position will work collaboratively with clinicians, biostatisticians, and statistical programmers as well as external vendors in the planning, conduct, and analysis of clinical studies in all phases.

Day-to-Day Responsibilities:
  • Provide timely and scientifically sound statistical expertise to clinical development projects.
  • Interact with members of project teams, clinical scientists, clinical pharmacologist, statistical programmers and data management personnel to establish project timelines, data validation checks and perform statistical analyses.
  • Lead, manage and provide technical support for statisticians working within the same clinical development program.
  • Responsible for providing statistical expertise in across studies in a program and in clinical study design. Collaborate in the preparation and review of protocols, CRF design and clinical study reports.
  • Develop statistical analysis plans, perform exploratory data analysis as necessary and provide data interpretation.
  • Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results. Provide guidelines and standards to CROs to ensure quality of deliverables.
  • Collaborate with researchers and thought leaders in publication of study data.


Requirements:
  • Candidate should be experienced in clinical drug development, regulatory requirements/interactions and have in depth knowledge of clinical trials design.
  • Must have experience in analysis and reporting of clinical trials and regulatory requirements.
  • Must have experience managing other statisticians and being the project manager for programs from biostatistics perspective.
  • Must have good communication skills, ability to be point of contact for biostatistics within a project/molecule and ability to coordinate across functional areas.
  • Must have sound understanding of statistical application for clinical trials.
  • Proficient in using statistical software (SAS required.)
  • MS/PhD (PhD preferred) in statistics or biostatistics or related field (8+ years of experience)


EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice