drjobs Principal Biostatistician

Principal Biostatistician

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1 Vacancy
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Job Location drjobs

Fairfield, CA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Description

Contact: Neisha Camacho/Terra Parsons -
No 3rd party agencies

Job Description:
The Principal Biostatistician will be responsible for performing and validating statistical analyses in support of Medical Affairs inclusive of overseeing the work of programming for external vendors in accordance with departmental SOP and guidelines as needed and sit within the Medical Affairs Statistics Epidemiology and RWE branch of the Data Sciences department.

Primary Responsibilities:
  • Develop design and oversee or perform post-hoc analyses of existing databases and meta-analyses as needed and appropriate
  • Support clinical development biostatistics with exploratory analyses necessary for submissions and regulatory queries.
  • Work collaboratively with members of study teams to meet study and recurring report timelines.
  • Support the development and implementation of study protocols.
  • Review and contribute to protocol eCRF design dataset specifications plans at study level in accordance with best practices.
  • Develop and review SAP TLF Shells statistical reports and other key study documents.
  • Review and provide input to study-specific data capture systems and participate in their validation.
  • Create and document archives of programs outputs and analysis files.
Minimum Requirements:
  • Masters degree with >2 years of experience; OR PhD in statistics mathematics or a related discipline with a statistical focus.
  • Proficient in drug development regulations pertinent to statistical analysis and in the and Oncology/Neuroscience therapeutic space
  • Proficient SAS & R programming skills
  • Understanding of CDISC SDTM and ADAM models and standards is preferred but not required.
  • Excellent writing and communication skills demonstrated leadership abilities and excellent interpersonal skills.
  • Able to work in a fast-paced flexible team-oriented environment.

Required Experience:

Staff IC

Employment Type

Contract

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