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Principal Biostatistician

EPM Scientific
Trenton, NJ Full Time
POSTED ON 2/25/2025
AVAILABLE BEFORE 5/11/2025

We have a current opportunity for a Principal Biostatistician on a permanent basis. The position will be remote. For further information about this position please apply.

Job Title : Principal Biostatistician

Location : Remote

Job Type : Full-Time

About Us : We're partnered with a leading Contract Research Organization (CRO) dedicated to providing high-quality clinical research services to the pharamceutical industry.

Job Summary : We are seeking a highly skilled and experienced Principal Biostatistician to join our dynamic team. The Principal Biostatistician will play a critical role in the design, analysis, and interpretation of clinical trials, ensuring the integrity and accuracy of statistical data. This position requires a deep understanding of biostatistics, clinical trial methodology, and regulatory requirements.

Key Responsibilities :

  • Lead the statistical design and analysis of clinical trials, including the development of statistical analysis plans (SAPs).
  • Provide expert statistical consultation to project teams, clients, and regulatory agencies.
  • Ensure the accuracy and integrity of statistical data and results.
  • Collaborate with cross-functional teams, including clinical operations, data management, and medical writing.
  • Develop and validate statistical models and methodologies.
  • Prepare and review statistical sections of clinical study reports, regulatory submissions, and publications.
  • Stay current with industry trends, regulatory guidelines, and best practices in biostatistics.
  • Mentor and train junior biostatisticians and other team members.

Qualifications :

  • Ph.D. or Master's degree in Biostatistics or Statistics
  • Minimum of 5 years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO industry.
  • Strong knowledge of clinical trial design, statistical methodologies, and regulatory requirements (e.g., ICH, FDA, EMA).
  • Proficiency in statistical software (e.g., SAS, R).
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Strong problem-solving and analytical skills.
  • Experience with regulatory submissions and interactions with regulatory agencies is a plus.
  • Benefits :

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and supportive work environment.
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