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
Pharmapace offers competitive salaries plus stock options, 401K plan with company match, health/dental/vision insurances, and holiday/vacation benefits. Pharmapace is an equal opportunity employer. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin/ancestry, age, disability, marital status, and veteran status.