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

Job Level

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

Location

Permanent Home-based

Why DSSS?

Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all the benefits of working for an industry leading global CRO and collaborating directly with cross‑functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.

Job Summary

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

• Strong experiences in end‑to‑end statistical support across the product lifecycle, including analytical method development and validation, formulation development and robustness, and process development and validation—aligned with regulatory standards such as FDA, EMA, ICH, and USP
• Good oral and written skills are crucial, as is the desire to learn enough of the relevant science to interact effectively.
• Exposure to modern data analysis techniques and experiences such as data visualization, robust statistics and analysis of high‑dimensional data is desirable.
• Constantly eager to expand statistical, communications, and computing expertise.
• Must enjoy the process of building long‑term collaborative relationships, be at ease with either a non‑rigid or rigid structure to projects and be organized in handling numerous projects simultaneously.

Qualifications

• PhD in Statistics or related field
• Strong experience in Statistical Support of CMC is a must
• Solid knowledge of linear mixed models, multivariate analysis, design of experiments and Bayesian statistics is essential.
• Proficiency in the R language is required with the development of automated, reproducible workflows using R Markdown and Quarto to enhance regulatory submission readiness.
• Demonstrated written, oral, and personal communication skills.
• Ability to work autonomously and within a team environment.
• Demonstrated ability to work in interdisciplinary contexts outside statistics.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.