Biostatistician

Penfield Search Partners

Posted on : 24-05-2025

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1 Vacancy

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Job Location

Fairfield, CA - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 24-05-2025

Job Description

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

Primary Responsibilities

Provides support for all activities related to clinical development including development of key study and program hypotheses clinical development plans study designs regulatory meetings submissions and follow up
Applies innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g. modeling and simulation adaptive design and/or Bayesian approaches)
Ensures accurate statistically valid deliverables in protocols statistical analysis plans study reports manuscripts and regulatory submission documents
Coordinates simultaneous achievement of major statistical deliverables and milestones for multiple clinical trials across the portfolio in collaboration with the clinical development team and other functions
Leads and manages internal/external biostatistics resources supporting studies and programs
Collaborates with data management and statistical programming to provide timely and accurate biostatistics deliverables
Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines
Responsible for providing statistical input and leadership for preparation of marketing applications (NDA/BLA) to FDA EMA or other worldwide regulatory agencies
Collaborates with Data Management and Statistical Programming to build our internal capabilities and develops standard processes for CDISC compliant data sets (SDTM and ADaM) performing formal tables listing & figure production and QC in preparation for submission readiness
Serves as a strategic partner with clinical team to aid in quantitative clinical decisions

Experience:

PhD in Biostatistics/Statistics or equivalent with a minimum of 5 years relevant work experience or MS in Biostatistics/Statistics or equivalent with a minimum of 10 years relevant experience
Candidates must have strong simulation experience using R with some SAS capability as well
Extensive experience with IND/NDA activities and regulatory interactions including filing ISS and/or ISE experience
Experience with interim analysis design conduct and manage/support data monitoring committee
Excellent SAS programming and analytical skills to develop programs to QC using SAS/BASE SAS/STAT SAS/GRAPH and SAS Macros.
Knowledge of GCP/ICH guidelines for conducting clinical trials
Pharmaceutical experience with clinical trials including familiarity with expectations of regulatory agencies especially the FDA
Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses etc.
Able to manage multiple projects and conflicting priorities and to be flexible when priorities change
Effective team player with willingness to go the extra distance to deliver results meet/exceed deadlines etc.
Excellent written and verbal communication

Nice to have: Machine Learning using R and/or Python; experience in an agile environment

Employment Type

Contract

Company Industry

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About Company

Penfield Search Partners

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