Job Description

Job Level: Non-Clinical CMC Statistician FSP

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 non-clinical Statistician will employ statistical design tools and techniques to support process analytical method and formulation development of medical or pharmaceutical products throughout their lifecycle.

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.
• 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 than project budgets and change orders.
• Experience with regulatory submissions.
• Engaging fast-paced environment.
• Good work-life balance.

Key Responsibilities:

• Collaborate with subject matter experts to design experimental studies plan and perform statistical analysis and document results in technical reports in support of business decisions regulatory submissions and compliance.
• Provide statistical support for a wide range of non-clinical applications including: particle size and distribution in-vitro bioequivalence assessments analytical method optimization and validation process development and platform characterization and stability studies to understand control and ensure product quality
• Ensure compliance with regulatory and ISO requirements for the statistical methods employed.
• Develop implement and maintain statistical tools used to support product life cycle activities.
• Promote good statistical practice across the team and mentor colleagues in statistical techniques and software tools.
• Stay up to date on best practices industry trends and regulatory guidance.
• Support other non-clinical statistical applications when needed.
• Support regulatory audits by responding to questions during on-site inspections and providing written responses to clarify statistical approaches or perform additional analyses.

Qualifications:

• Doctorate Degree in Statistics or a related field plus 2 years minimum of relevant applied statistics experience OR
• Masters Degree in Statistics or a related field plus 5 years minimum of relevant applied statistics experience OR
• Bachelors Degree in Statistics or a related field plus 10 years minimum of relevant applied statistics experience.
• Proficient in the following: non-clinical applications including particle size and distribution in-vitro bioequivalence assessments analytical method optimization and validation process development and platform characterization and stability studies to understand control and ensure product quality
• Experience and/or training in design of experiments including optimization or robustness experimental designs.
• Proficient in statistical techniques commonly used in pharmaceutical manufacturing operations such Statistical Process Control Process Capability Analysis Measurement System Analysis Acceptance Sampling Non-linear and Linear Regression Significance Testing and Simulation.
• Skills in machine learning or Bayesian methods are a plus.
• Proficient in SAS and/or R programming including data manipulation macros functions statistical and graphical packages and quality output production; JMP or R-Shiny skills are a plus.
• Good understanding of pharmaceutical development and CMC activities in a regulatory context including GMP and Quality by Design framework.
• Excellent communication and collaboration skills.
• Demonstrated ability to work independently and pro-actively to deliver top quality work product.

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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.

The potential base pay range for this role when annualized is $105800.00 - $294800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge skills education and experience; location; and/or schedule (full or part-time). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.

Required Experience:

IC

Job Tags

Full time, Part time, Immediate start, Remote work, Work from home, Worldwide, Flexible hours

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