About the job Pharmapace welcomes qualified and motivated candidates to apply for the Principal Statistician position. Pharmapace is a fast growing and specialized consulting/outsourcing company serving the biotech and pharmaceutical companies in their clinical development programs. We offer a stimulating working environment and excellent career growth opportunity. The primary responsibilities of this position are to provide statistical consulting to clients in the biotech/pharmaceutical industry in their drug development programs with a focus on protocol/study design, analysis planning, and regulatory submission strategies. Key Responsibilities Provide statistical consulting for clinical study design Review study protocols and write statistical sections Conduct sample size and power calculations Propose randomization methods and designs Lead regulatory submission strategy planning for statistics function Identify issues, and provide solutions to clinical operation and data management for issues that potentially impact data analyses Develop and review statistical analysis plans, both for individual studies and integrated analyses for regulatory submissions Write statistical reports for results interpretation, both for individual studies and integrated analyses for regulatory submissions, if needed Prepare statistical sections of clinical study reports and provide statistical interpretation for study report preparation Participate in clinical results interpretation meetings Work with medical writers to assist with clinical study reports and ISS/ISE reports preparation Review clinical study reports and other regulatory submission documents Advise clients in drug approval and submission process and interact with regulatory agencies Identify and resolve statistical issues. Research and stay current with innovative statistical methodologies Supervise and mentor junior statisticians

QUALIFICATIONS

Education:

Master's or Doctoral degree in Statistics, Biostatistics or Epidemiology Experience Master's degree with 8+ years or Doctoral degree with 5+ years of relevant experience in a health sciences research institute or the pharmaceutical/biotech industry Direct participation in design, planning, conduct, analyses, and reporting of clinical trials Direct participation in regulatory submission activities Skills Deep understanding statistical concepts and methodology related to clinical trials and drug development Working knowledge of SAS and/or R Comprehensive knowledge on regulatory guidelines Excellent organizational and project management skills Highly motivated. Excellent interpersonal and communication skills

Compensation Range:

$130K - $210K Pharmapace offers competitive salaries plus stock options, 401K plan with company match, health/dental/vision insurances, and holiday/vacation benefits.