2rbConsulting is looking to hire an experienced Biostatistician for a contract role in Andover, MA. Our client is a well-known & respected leader in the Pharmaceutical industry. The individual in this role will primarily be responsible for providing statistical consultation and data analysis support to the company’s derived drug manufacturing operations.
- Estimate analytical measurement and manufacturing process variabilities
- Responsible for recommending quality control (QC) assay limits and evaluate assay performance
- Recommend test designs and acceptance criteria for analytical method validations
- Perform stability analysis of drug products, and estimate stability profiles and shelve lives
- Responsible for supporting investigations of deviations, and unusual and out of specification results
- Author formal reports of statistical conclusions and results
- 5-7+ years of experience as a Biostatistician
- Extensive experience with biostatistics software (JMP or Minitab)
- Prior work experience in the pharmaceutical industry in a cGMP environment
- Strong knowledge of SPC charts, design of experiments, hypothesis testing, and statistical modeling
- Proficient with Microsoft Office (Excel functions, VBA, Word, and PowerPoint)
- Strong knowledge of cGMPs, FDA/EMA and other regulatory guidelines (e.g., ICH, USP, EP) as applied to drug manufacturing
- Extensive experience in authoring technical reports or professional journal articles
- Must have excellent written/verbal communication skills
- Master of Science Degree or Ph.D. in statistics, mathematics, or related discipline
If this opportunity is a good match for your background, skills, and career goals, please submit your resume for immediate consideration! Local candidates highly desired, and candidate must be eligible to work in the US without sponsorship. PLEASE, NO 3rd PARTY CANDIDATES.
Rosanne has 10 years of exclusive Healthcare IT recruiting experience along with bioinformatics and the pharmaceutical industry. She is determined to helping her candidates find their next opportunity and is dedicated to her candidates as they take the next step in their career path. Rosanne’s ability to identify high-quality candidates ensures that every individual she places is a great hire!