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Director, Biostatistics

Director, Biostatistics

Rapport TherapeuticsBoston, MA, United States
Hace 4 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Overview

Join to apply for the Director, Biostatistics role at Rapport Therapeutics .

Rapport Therapeutics is focused on precision neuromedicine. Our led programs include RAP-219, with indications targeting focal epilepsy and trials in neuropathic pain and bipolar disorder.

Your Impact

Rapport is seeking a Director or Senior Director of Biostatistics who will shape the design, analysis, and interpretation of clinical trial data for our precision neuromedicine programs. Reporting to the VP of Biometrics, you will collaborate with multidisciplinary teams to advance therapies, ensuring statistical rigor and high data integrity throughout the drug development process.

Your Day-to-Day

  • Contribute to the design of clinical trials, including writing or reviewing statistical sections of protocols and statistical analysis plans (SAPs).
  • Perform and validate statistical analyses of clinical trial data using SAS and / or R in accordance with regulatory and internal standards.
  • Support the generation of tables, listings, and figures (TLFs) and contribute to the interpretation of results.
  • Collaborate with Clinical and Regulatory teams to provide statistical input to study reports, regulatory submissions, and publications.
  • Participate in the development and review of case report forms (CRFs) and data management plans to ensure accurate data collection aligned with study objectives.
  • Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA).
  • Assist in the development, validation, and documentation of statistical methodologies and processes.
  • Oversee and manage external CROs and vendors to ensure high-quality and timely deliverables.
  • Participate in cross-functional team meetings, providing statistical support and insights to influence decision-making.
  • Ensure all statistical activities comply with regulatory guidelines and company policies.
  • Assist in the preparation of regulatory documents, including INDs and NDAs.
  • Contribute to the development of internal statistical processes, SOPs, and initiatives.

Must-Haves

  • PhD with 10+ years of experience (12+ for Senior Director) OR MS with 12+ years of experience (15+ for Senior Director) in statistics, biostatistics, or a closely related discipline within the pharmaceutical or biotech sector.
  • Title and compensation commensurate with experience.
  • CNS therapeutic area experience is a plus.
  • Skilled in SAS or R, or Python for data analysis, graphing, and simulation.
  • Comprehensive knowledge of clinical trial design, advanced statistical analysis methods, and familiarity with regulatory guidelines (FDA, EMA, ICH).
  • Extensive knowledge of CDISC standards (SDTM, ADaM) and best practices for data collection, analysis, and reporting.
  • Ability to communicate complex statistical concepts clearly to non-statistical audiences.
  • Strong attention to detail, organizational skills, and ability to manage multiple projects in a fast-paced environment.
  • Proven collaboration, leadership, and organizational skills.
  • Significant experience with global regulatory agency interactions.
  • Experience in resource planning, recruiting, and defining organizational needs with senior leaders.
  • What Makes Rapport Special

  • Every role has meaning and a passion for helping patients.
  • We are driven to innovate with exciting science that pushes boundaries.
  • Your perspective matters – we work as a team.
  • We have fun – we hire smart, dedicated, down-to-earth people.
  • Leadership that cares about you, your growth and development.
  • We are bicoastal – San Diego and Boston options with hybrid opportunities.
  • Your Compensation

    We understand compensation is important. The anticipated hiring range for this role is $235,000 to $255,000 for Director level or $270,000 to $295,000 for Senior Director level. Offers will reflect relevant skills, experience, location, market data, and internal equity. In addition to a competitive salary, Rapport offers a comprehensive benefits package and fully disclosed salary ranges for every level.

    Hybrid Work Environment

    We prioritize in-person connection. Onsite work is in our Boston office on Tuesday and Wednesday. Starting January 2026, the schedule will shift to three days per week to enhance collaboration and innovation.

    Rapport Therapeutics is an equal opportunity employer and will not discriminate on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any other protected category.

    Note to Employment Agencies : Please do not forward agency resumes. The company is not responsible for fees related to unsolicited resumes.

    CCPA disclosure notice can be found here.

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    Director • Boston, MA, United States

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