Bioinformatics / Baltimore, Maryland

Biostatistician II

Job Description

PGDx seeks a motivated, professional Biostatistician (Master’s level or higher) who will provide company-wide statistical and data management support for product design, development, product transfer, production, clinical trials and quality assurance, as well as statistical and data transfer input to study design and analysis for registrational/​premarket approval pivotal studies (CE-IVD and US-IVD) of qualitative and quantitative IVD assays.

Key Responsibilities

  • Provide subject matter expertise in study design, data transfer, data management and data analysis
  • Work closely with project team members from regulatory, research and development, clinical affairs, medical affairs, project management, product transfer, manufacturing and quality on the appropriate use of statistical methods
  • Select appropriate statistical tools for addressing scientific questions
  • Write and edit statistical analysis plans and relevant sections of study reports
  • Analyze datasets, provide data management support, present, communicate and document results and conclusions
  • Summarize data analysis results orally and in written form
  • Support responses to queries from regulatory bodies regarding statistical aspects of studies, data management activities, and data transfer
  • Develop statistical training programs for other departments in the company

Required Education & Experience

  • Master’s or PhD degree in Statistics or Biostatistics or related field
  • 3 — 5 years of experience in work directly related to biostatistics
  • Experience with pre-submission dialog with the FDA a plus
  • Good programming skills and knowledge of R; simulation experience a plus
  • Demonstrated excellence in at least one area of statistics: clinical or analytical studies for in vitro diagnostics (IVDs); ROC analysis; experimental design and analysis of variance; Design of Experiments (DOE); statistical quality control; data analysis and data transfer for clinical trials; observational studies; missing data; survival analysis; statistical genetics; computation statistics; propensity scores; drug or device or biologics registration trials
  • Able to prioritize work and complete deliverables to timelines
  • Outstanding ability to communicate orally and in writing technical information to both technical and non-technical audiences
  • Knowledge of CDISC standards including SDTM/​ADaM requirements for data submissions to regulatory agencies

About Personal Genome Diagnostics

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic technologies for drug development and clinical practice.

Please submit applications (cover letter and resume) to HR@​personalgenome.​com
Special consideration will be given to internal PGDx employees who apply.

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