Associate Director Biostatistics

Connect Life Sciences; Massachusetts; Híbrido; USD 180.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation assistance

Descripción de la vacante

Connect Life Sciences in the Greater Boston area seeks a Senior Manager/Associate Director/Director of Biostatistics to lead statistical strategy across early to late-phase clinical programs. The role emphasizes ownership of study design, SAPs, and regulatory submissions within a fast-paced biometrics team.

Immunology experience is preferred; candidates from other therapeutic areas with strong leadership and development expertise will be considered.

Formación

• Advanced degree in Statistics/Biostatistics or related quantitative field.
• 6+ years of clinical trial experience in biotech/pharma.
• Phase I experience required; support across I–III.
• Hands-on SAS programming is required.
• Familiarity with FDA/EMA/ICH guidelines.

Responsabilidades

• Lead statistician for assigned studies or programs.
• Provide strategic statistical input into development plans and study designs.
• Oversee SAPs, CSRs, and statistical deliverables; review CRO outputs.
• Contribute to regulatory submissions and interactions.
• Mentor and potentially manage junior staff.

Conocimientos

SAS programming

Statistical leadership

Communication

Project management

Biostatistics knowledge

Educación

Advanced degree in Statistics/Biostatistics

Herramientas

SAS

R

Python

EAST

nQuery

Descripción del empleo

Senior Manager / Associate Director / Director, Biostatistics

Location:

Watertown, MA | Hybrid

Relocation Assistance Available

Position Overview

We are partnering with a clinical-stage biotechnology company seeking an experienced Biostatistician to join its growing Biometrics organization. The team is open to considering candidates at the Senior Manager, Associate Director, or Director level, depending on experience.

This individual will serve as a Study/Program Lead Statistician, taking ownership of statistical strategy and execution across clinical development programs. The position offers significant visibility and the opportunity to contribute from early-stage development through later-phase clinical trials and regulatory activities.

Experience within Immunology is preferred; however, candidates from other therapeutic areas with strong clinical development and statistical leadership experience are encouraged to apply.

Key Responsibilities

• Serve as the lead statistician for assigned clinical studies and/or development programs.
• Represent Biostatistics/Biometrics on cross-functional study and program teams.
• Provide strategic statistical input into clinical development plans and study designs.
• Lead statistical activities across Phase I–III clinical trials, with strong early-phase experience required.
• Author statistical sections of clinical protocols and provide statistical review of other study documentation.
• Develop and review Statistical Analysis Plans (SAPs) and statistical output shells.
• Contribute to integrated analyses, including ISS and ISE, as applicable.
• Provide statistical input into CRF design and clinical database development.
• Oversee and perform quality review of statistical programming deliverables.
• Author statistical sections of Clinical Study Reports and support interpretation of clinical trial results.
• Contribute to regulatory submissions, agency interactions, and inspection readiness.
• Manage statistical deliverables performed by CROs and external vendors.
• Support scientific publications, presentations, and other clinical development activities.
• Provide mentorship and potentially manage direct reports depending on level.

Qualifications

• Advanced degree in Statistics, Biostatistics, or a related quantitative field.
• Approximately 6+ years of clinical trial experience within biotechnology or pharmaceutical environments; level will be determined based on experience.
• Phase I clinical trial experience is required, along with broader experience supporting clinical development across Phases I–III.
• Strong knowledge of statistical methodologies used in clinical trials.
• Hands-on SAS programming experience is required.
• Strong understanding of FDA, EMA, and ICH guidelines and their application to clinical development.
• Experience contributing to clinical protocols, SAPs, CSRs, regulatory submissions, and statistical deliverables.
• Experience overseeing CROs and/or outsourced statistical programming activities.
• Ability to effectively communicate statistical concepts to clinical and non-statistical stakeholders.
• Strong organizational skills with the ability to manage multiple studies and priorities in a fast-paced biotech environment.
• Immunology experience is highly preferred, though strong candidates from other therapeutic areas will be considered.
• Experience with R, Python, EAST, or nQuery is a plus.

Additional compensation may include annual bonus, equity, and comprehensive benefits.

Location & Relocation

Candidates who are not currently local to the Greater Boston area are encouraged to apply, as relocation assistance is available.

This is an urgent hire, and the team is actively interviewing qualified candidates.