Biotech/Pharmaceutical

Biostatistician – Remote

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Responsibilities:

  • Responsible for strategic statistical and ‘hands on’ day to day support for studies in support of clinical programs.
  • Validation of the statistics from the vendor/vendor oversight
  • QC the models from the vendor, will also be responsible for doing some modeling.
  • Sensitivity analysis and understanding the estimands paradigm.
  • Quality assure and validate statistical outputs (TFLs) and develop/review ADaM specifications and datasets, interpret and clearly communicate statistical results and concepts to non-statisticians.
  • Interface with data management, clinical science, and clinical operations on a day-to-day basis.
  • Initiate, drive, and implement novel methods and innovative trial designs.
  • Provide statistical input into protocol and case report form (CRF) development (e.g., trial design, sample size estimation, statistical methods for protocols, edit checks for clinical trial data)
  • Participate in regulatory (e.g., pre-IND, NDA) activities including authoring of statistical sections and participating in regulatory meetings/written responses.
  • Contribute to planning and execution of exploratory analyses, data visualization and statistical consultation on cross-functional teams.
  • Write statistical analysis plans. Design and develop tables, listings, and figures (mock TLFs).  Partner with programming on analysis datasets and review of TLFs.

Qualifications:

  • PhD or equivalent with 7-10 years of experience
  • Regulatory submission experience
  • Excellent communication skills are a key requirement.
  • Experience managing statistical vendors is a must.

Pay rate: $90-110 hourly W2 OR $110-130 hourly on 1099

Tagged as: Biostatistician - Remote