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Lead Quantitative Clinical Pharmacologist
Lead Quantitative Clinical PharmacologistCytel • Boston, MA, United States
Lead Quantitative Clinical Pharmacologist

Lead Quantitative Clinical Pharmacologist

Cytel • Boston, MA, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Who Are You?

As a passionate and seasoned Pharmacometrician, you thrive in the realm of clinical development and analysis, using your expertise in advanced statistical methods to lead the charge in quantitative pharmacology activities for clinical studies. Your enthusiasm is contagious, motivating your teams to excel, and your collaborative spirit fosters strong relationships with clients. You are committed to not just maintaining the status quo but constantly advancing clinical development to its fullest potential, inspiring others to do the same.

Why Join Us?

In this opportunity, you will work closely with one of our esteemed pharmaceutical clients, benefiting from the robust support of Cytel as you contribute to innovation in patient treatment. This role allows you to work autonomously while taking ownership of impactful projects during an exciting phase of development.

Position Overview :

As a Lead Pharmacometrician, you will provide comprehensive analytical and development support for clinical trials, combining your deep understanding of processes and regulatory strategies with advanced modeling techniques. Your leadership will guide cross-functional teams and ensure alignment on strategies that propel our client's research forward.

Your Responsibilities Will Include :

  • Driving Pop-PK and PK / PD modeling, as well as conducting non-compartmental analyses.
  • Contributing to the design of studies utilizing Bayesian and adaptive methodologies.
  • Defining specifications and performing comprehensive analyses including time-to-event and longitudinal assessments.
  • Reviewing and shaping study reports as well as quantitative clinical pharmacology sections for regulatory submission, leading the electronic submission of clinical data, and participating in discussions with regulatory authorities.
  • Building strong collaborative relationships and effective communication with the sponsor's cross-functional teams and Biostatistics management.

Required Qualifications :

  • Proven experience in Pop-PK and PK / PD modeling, alongside expertise in non-compartmental analyses.
  • A solid grasp of the broader biopharmaceutical R&D landscape.
  • Exceptional organizational and multi-tasking capabilities with robust problem-solving and analytical skills.
  • Proficiency in Phoenix WinNonLin, NLME, and R.
  • Cytel Inc. is an Equal Employment / Affirmative Action Employer. We welcome applicants for all positions regardless of race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

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