No H1B and/or C2C please!!
Industry experience Required: Pharma/Biotech/Medical Devices
One of our leading Pharmaceutical client is looking for a Biostatistician / Process Engineer (Biologics Statistic Data), this person will beresponsible for applying established commercial biologics Continued Process Verification (CPV) program strategies. Also support batch processing data collection and verification activities.
Job Title: Biostatistician / Process Engineer (Biologics Statistic Data)
W2 Contract & Onsite role
Work Location: Parsippany, NJ
Required
• Experience with optimization and statistical data analysis tools such as Minitab, JMP, Spotfire and R. Basic programming in R and Python preferred
• Excellent technical writing skill
• Understanding of guidelines required by FDA, ICH, EMA, and other regulatory bodies
• Strong background in statistics, Continued Process Verification (CPV) and advanced statistical data analysis.
Responsibilities:
• Apply established commercial biologics Continued Process Verification (CPV) program strategies and contribute to CPV program of one or multiple biologics products.
• Author, review and approve CPV protocols, reports and present CPV data as needed to Subject Matter Experts (SMEs).
• Support batch processing data collection and verification activities.
• Identifies and implements improvements for data collection and management to enable quick and reliable data analysis.
• Provides statistical expertise for all global commercial process monitoring in compliance with current ICH / Health Authority, QbD guidelines and SOPs.
• Assist in resolution of investigations doing statistical analysis.
• Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
If you are a right fit as per the skills requirements and this job excites you then please apply quick!!
