Director of Biostatistics - Middletown, PA, United States - Phoenix Industries

Phoenix Industries
Phoenix Industries
Verified Company
Middletown, PA, United States

3 weeks ago

James Miller

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James Miller

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Freelance
Description
Proclinical is currently seeking a Director of Biostatistics for a biotech company located in Middletown, PA. This is a permanent position with the option to work remotely from anywhere in Germany. The company is dedicated to improving the health of individuals.


Responsibilities:


  • Oversee outsourced statistical activities and ensure high quality deliverables.
  • Act as the statistical representative in crossfunctional project and study teams.
  • Communicate with international regulatory authorities.
  • Conduct sample size calculations, develop statistical analysis plans, and guide TFL development.
  • Assist in the development of divisional strategies.
  • Other duties as assigned.

Key Skills and Requirements:


  • Advanced degree in statistics or biostatistics.
  • Minimum of 4 years (6 years if holding a master's degree) of experience in a pharmaceutical company or CRO with submission experience.
  • Knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA), and statistical software (SAS, EAST, R).
  • Ability to think critically, prioritize quality, and find innovative solutions.
  • Familiarity with clinical study designs in cell and gene therapies (CAR-T, iNEST, etc.) is preferred.
Proclinical is a specialized recruitment agency that provides job opportunities in the pharmaceutical, biopharmaceutical, biotechnology, and medical device industries.

Proclinical Staffing is an equal opportunity employer.

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