**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._ **\#LI-Remote** 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 https://jobs.iqvia.com 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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled