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Principal Biostatistics Specialist

2 months ago

Stamford, Connecticut, United States Penfield Search Partners Full time
Job Overview

Company: Penfield Search Partners

Position Summary: As a Senior Biostatistician, you will play a pivotal role in guiding the statistical framework and providing hands-on support for multiple clinical studies. Your expertise will be crucial in leading statistical initiatives, collaborating with project teams, and developing comprehensive statistical designs and analysis plans.

Key Responsibilities:

  • Direct the statistical approach for various clinical studies while actively participating as a core team member.
  • Assume accountability for the statistical design, analysis, and reporting of clinical trials across all phases, ensuring compliance with industry standards.
  • Innovate and implement advanced statistical methodologies and trial designs.
  • Contribute statistical insights during protocol and case report form development, including trial design and sample size estimations.
  • Engage in regulatory activities, including drafting statistical sections and participating in meetings.
  • Support exploratory analyses, data visualization, and statistical consultation across multidisciplinary teams.
  • Collaborate with various departments to ensure timely and high-quality statistical deliverables.
  • Engage with external stakeholders, including consultants and advisory boards, to enhance project outcomes.
  • Draft statistical analysis plans and create tables, listings, and figures for reporting purposes.
  • Ensure the quality and validation of statistical outputs, clearly communicating results to non-statistical audiences.
  • Provide statistical support for presentations, manuscripts, and regulatory documents.
  • Develop and refine statistical standard operating procedures and contribute to standardization initiatives.
  • Stay updated on advancements in statistics and regulatory guidelines through continuous learning.

Qualifications:

  • PhD in Biostatistics or Statistics with a minimum of 6 years of experience in the pharmaceutical or CRO sectors (MS candidates with relevant experience may be considered).
  • Proven experience in reporting clinical trial data in accordance with CDISC standards.
  • Demonstrated involvement in regulatory submissions.
  • Extensive knowledge of statistical methodologies, including Mixed Models and Bayesian approaches, with proficiency in SAS and R.
  • Ability to work effectively within cross-functional teams to achieve successful regulatory outcomes.
  • Strong communication skills, with the ability to convey complex statistical concepts to diverse audiences.
  • Flexibility and adaptability to meet the evolving needs of the organization.
  • Strong organizational skills with the ability to manage multiple priorities.
  • Experience in rare diseases or gene therapy development is preferred.
  • Advanced programming skills in SAS and R are essential.
  • Expertise in ADaM specifications and datasets is required.
  • Experience in drafting statistical analysis plans and mock TFLs for clinical reporting.
  • Background in collaborating on clinical study design and sample size calculations.
  • Experience in supporting DSURs, IBs, and DMCs.