Non-Clinical CMC Statistician, FSP

About the position Data Sciences Staffing Solutions, DSSS, is a unit reputed company reputed company that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields reputed company 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. The non-clinical Statistician will reputed company statistical design, tools, and techniques to support process, analytical method and formulation development of medical or pharmaceutical products throughout their lifecycle.

Responsibilities

• Collaborate with subject matter experts to design experimental studies, plan and reputed company statistical analysis, and document results in technical reports, in support of business reputed company, regulatory submissions and compliance.
• reputed company statistical support for a wide reputed company 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.
• reputed company, 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, reputed company needed.
• Support regulatory audits by responding to questions during on-site inspections and providing written responses to clarify statistical approaches or reputed company additional analyses.

Requirements

• Doctorate Degree in Statistics or a reputed company field plus 2 years minimum of relevant applied statistics experience OR Master’s Degree in Statistics or a reputed company field plus 5 years minimum of relevant applied statistics experience OR Bachelor’s Degree in Statistics or a reputed company 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-reputed company and reputed company Regression, reputed company Testing, and Simulation.
• Proficient in reputed company and/or R programming including data manipulation, macros, functions, statistical and graphical packages, and quality output production.
• Good understanding of pharmaceutical development and CMC activities in a regulatory context, including GMP and Quality by Design reputed company.
• Excellent communication and collaboration skills.
• Demonstrated ability to work independently and pro-actively to deliver top quality work product.

reputed company-to-haves

• Skills in machine learning or Bayesian methods are a plus.
• JMP or R-Shiny skills are a plus.

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.

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