FSP Principal Biostatistician Chemistry, Manufacture and Control (CMC)

Job Level: FSP Principal Biostatistician - Chemistry Manufacture and Control (CMC)

Location: Home-based in the U.S. or Canada

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.

Additional Benefits:

• Home-based remote working opportunities.
• Work/life balance as well as flexible schedules.
• Collaborating with motivated high-performance statistical and research teams.
• Technical training and tailored development curriculum.
• Learning through application of statistical methods in ones daily work
• Research opportunities that match your unique skillset.
• Promising career trajectory.
• Job stability: long-term engagements and re-deployment opportunities.
• Focus on bringing new therapies to market rather.
• Experience with regulatory submissions.
• Engaging fast-paced environment.
• Good work-life balance.

Job 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

Qualifications (Minimal acceptable level of education work experience and competency)

• 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.

Desired Experience/Expertise:

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

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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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. 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.