Senior Statistical Scientist

2 weeks 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 providing strategic statistical guidance and hands-on support for multiple clinical studies. You will serve as the primary statistician for various projects, collaborating with study teams to develop robust statistical designs and analysis plans. Your expertise will be essential in conducting exploratory analyses using R/SAS, creating tables, listings, and figures for statistical reporting, and ensuring the integrity of data through close collaboration with programming teams.

Key Responsibilities:

  • Lead the statistical strategy for multiple clinical studies and actively participate as a core member of project teams.
  • Be accountable for the design, analysis, and reporting of Phase 1-4 clinical trials, including integrated analyses across studies.
  • Drive the implementation of innovative methodologies and trial designs.
  • Provide statistical input during protocol and case report form (CRF) development, including trial design and sample size estimation.
  • Engage in regulatory activities, contributing to the statistical sections of submissions and participating in regulatory meetings.
  • Plan and execute exploratory analyses, data visualization, and statistical consultation across various teams.
  • Collaborate with cross-functional teams to ensure timely and high-quality statistical deliverables.
  • Engage with external stakeholders, including consultants and advisory boards, to enhance project outcomes.
  • Develop and write statistical analysis plans, designing tables, listings, and figures in partnership with programming teams.
  • Ensure quality assurance and validation of statistical outputs, interpreting results for non-statistical audiences.
  • Support the preparation of conference presentations, manuscripts, and clinical study reports.
  • Contribute to the development of statistical standard operating procedures (SOPs) and participate in standardization efforts.
  • Stay informed about advancements in statistics, drug development, and regulatory guidance through continuous learning.

Qualifications:

  • PhD in Biostatistics or Statistics with a minimum of 6 years of experience in the pharmaceutical or CRO industry (MS candidates with significant experience may be considered).
  • Proven experience in reporting Phase 1-3 clinical trial data to CDISC standards.
  • Experience in supporting regulatory submissions.
  • Strong statistical expertise in methodologies such as Mixed Models, Bayesian approaches, and Interim Analyses.
  • Ability to work effectively within cross-functional teams to achieve successful regulatory outcomes.
  • Excellent communication skills, with the ability to present complex statistical concepts clearly to non-statisticians.
  • Flexibility and adaptability to meet the evolving needs of the organization.
  • Strong organizational skills to manage multiple assignments and prioritize effectively.
  • Experience in rare diseases and/or gene therapy development is preferred.
  • Extensive proficiency in SAS and R programming.
  • In-depth experience in creating ADaM specifications and datasets.
  • Experience in writing statistical analysis plans and mock TFLs for clinical study reporting.
  • Experience in clinical study team collaboration for study design and sample size calculations.
  • Experience in supporting DSURs, IBs, and DMCs.

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