FSP Principal Biostatistician - Chemistry, Manufacture and Control (CMC)

IQVIA•Durham, NC

12d•Remote

About The Position

The Principal CMC Biostatistician is responsible for providing statistical support for a wide range of activities pertaining to pharmaceutical manufacturing.

Requirements

Ph.D. in Statistics, Biostatistics, or related field with 5+ years of industry experience.
M.S. in Statistics, Biostatistics, or related field with 7+ years of industry experience.
At least 3 years in statistical support of CMC.
Demonstrated ability to work pro-actively and independently.
Able to effectively communicate ideas and statistical concepts.
Expertise in R or JMP to perform data management, calculations, statistical analyses.
Understanding of regulatory guidance pertaining to drug manufacturing and general knowledge of industry practices and standards.

Nice To Haves

Design of experiments
Bayesian methods
Quality by design
Building, validating or testing statistical applications

Responsibilities

Contribute to the planning and analysis of experiments pertaining to drug manufacturing and quality.
Co-author statistical analysis plans and reports.
Collaborate with statisticians, engineers and scientists in providing statistical expertise.
Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming/validation of tables, listings, and figures.
Producing and validating statistical analyses, including those for regulatory submission.
Conduct data integrity reviews to ensure accuracy and traceability of data used in analyses.
Provide modeling, and visualizations of data from scientific studies, including laboratory data.
Support exploratory analyses.
Effectively comply with sponsor training, SOPs and processes for all work.
Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
Succeed in a dynamic, science-focused work environment
Advocate for good statistical practice in all projects