Associate Director Biostatistician - CRO

Posted 27 June 2024
Salary Negotiable
Job type Contract
Discipline CRO & Clinical Operations
Contact NameJames Aiton

Job description

We are partnered with a global CRO who are seeking an experienced and highly motivated Associate Director Biostatistician, with expertise in immunology or vaccines to join their team on a contract basis.

The successful candidate will play a key role in the design, analysis, and interpretation of clinical trials and other research studies within the immunology and vaccines therapeutic areas.

Associate Director Biostatistician - Responsibilities:

  • Provide statistical leadership and support for clinical development projects in the immunology and vaccines therapeutic areas

  • Collaborate with cross-functional teams including clinical development, regulatory, data management, and medical writing to ensure the successful design and implementation of clinical trials

  • Develop and review statistical analysis plans (SAPs) and ensure their alignment with clinical study protocols

  • Perform and oversee statistical analyses of clinical trial data, ensuring accuracy and adherence to regulatory guidelines

  • Prepare statistical sections of clinical study reports, regulatory submissions, and publications

  • Contribute to the design of study protocols, including sample size calculations and randomization plans

  • Participate in regulatory interactions and respond to health authority queries related to statistical aspects of clinical trials

  • Mentor and provide guidance to junior biostatisticians and other team members as needed

  • Stay current with industry trends, regulatory requirements, and advancements in statistical methodologies relevant to immunology and vaccines


Associate Director Biostatistician - Requirements:

  • Ph.D. or M.S. in Biostatistics, Statistics, or a related field

  • Strong experience in biostatistics within the pharmaceutical or biotechnology industry, with a focus on immunology or vaccines

  • Proven track record of successful contributions to clinical trials and regulatory submissions

  • Strong knowledge of statistical software (e.g., SAS, R) and advanced statistical methodologies

  • Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams

  • Demonstrated ability to manage multiple projects and priorities in a fast-paced environment

  • Strong problem-solving skills and attention to detail

  • Experience with adaptive trial designs, Bayesian methods, and other innovative statistical approaches (preferred)

  • Prior experience interacting with regulatory agencies (preferred)

  • Publications in peer-reviewed journals in the field of biostatistics or related disciplines (preferred)


Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.