(Sr. )Director, Biostatistics

CORXEL Pharmaceuticals; New Jersey; On-site; USD 180,000 - 280,000; Full time

Job summary

CORXEL Pharmaceuticals in New Jersey seeks a Director/Senior Director of Biostatistics to lead statistical strategy and delivery for late-stage programs, with hands-on technical contribution in study design, analyses, and regulatory interactions.

You will supervise CRO biostatistics and programming deliverables, collaborate with cross-functional teams, and mentor colleagues in a lean outsourced operating model, supporting global development efforts.

Qualifications

• PhD in Statistics or Biostatistics required with 8+ years pharma/biotech experience, or a Master’s with 10+ years.
• Independent leadership of Phase 2/3 or pivotal clinical programs and studies.
• Experience interacting with FDA or other major health authorities.

Responsibilities

• Lead statistical strategy and delivery for assigned development programs and studies, ensuring high-quality, timely deliverables.
• Provide statistical leadership for clinical development planning and study design, endpoints, sample size, estimands, multiplicity, analyses, missing data, and simulations.
• Review and contribute to protocols, SAPs, TLF shells, CSRs, briefing documents, and regulatory responses.
• Engage in regulatory strategy and interactions with FDA/EMA/other health authorities as relevant.
• Interpret results and communicate statistical implications to non-statistical stakeholders including leadership.
• Provide senior statistical oversight of CRO biostatistics and programming in outsourced models.
• Maintain depth to independently evaluate analyses and simulations using R and/or SAS.
• Contribute to fit-for-purpose statistical standards for a lean biotech operating model.

Skills

Statistical leadership

Regulatory interactions

SAS

R

Communication to stakeholders

CRO oversight

Education

PhD in Statistics or Biostatistics

Master's in a quantitative field (≥10 years experience)

Tools

R

SAS

CDISC SDTM/ADaM

Job description

The Director / Senior Director, Biostatistics will lead statistical strategy and delivery for one or more assigned clinical development programs. This senior individual-contributor role requires both strategic leadership and direct technical contribution in study design, protocols, analysis planning, regulatory interactions, interpretation of results, and senior technical oversight of CRO biostatistics and programming deliverables. The position will work closely with the Head of Biometrics and cross-functional teams in a lean, largely outsourced operating model. The primary focus will be late-stage and global development, with support for earlier-stage programs and portfolio activities as business priorities require.

Responsibilities

• Lead statistical strategy and delivery for assigned development programs and studies, with accountability for the quality and timely completion of statistical deliverables.
• Provide statistical leadership for clinical development planning and study design, including endpoints, sample size, estimands, multiplicity, interim analyses, missing-data approaches, and simulations, as applicable.
• Lead or provide review of protocols, statistical analysis plans, TLF shells, clinical study reports, briefing documents, and regulatory responses.
• Provide statistical leadership for regulatory strategy and interactions with global health authorities, such as the FDA, EMA, NMPA, and PMDA, as relevant to assigned programs.
• Interpret study results and communicate statistical implications clearly to Clinical, Regulatory, executive leadership, and other non-statistical stakeholders.
• Provide senior statistical oversight of CRO biostatistics and programming deliverables, including scope, assumptions, quality, timelines, and issue resolution, in partnership with internal Statistical Programming and Data Management.
• Maintain sufficient technical depth to independently evaluate, prototype, or challenge statistical analyses and simulations using R and/or SAS.
• Contribute to fit-for-purpose statistical standards, processes, and best practices appropriate for a lean biotech operating model.
• Mentor colleagues and contribute statistical input to portfolio evaluations, business development, and due-diligence activities as needed.

Required Education/Qualifications/Skills

• PhD in Statistics, Biostatistics, or a related quantitative field with 8+ years of relevant pharmaceutical/biotechnology experience, or a master's degree with 10+ years of relevant experience.
• Demonstrated independent leadership of Phase 2/3 or pivotal clinical development programs and studies.
• Direct experience preparing for or participating in interactions with FDA or another major health authority.
• Strong knowledge of clinical trial design, regulatory statistical expectations, and relevant ICH guidance.
• Experience developing and reviewing protocols, statistical analysis plans, analysis specifications, and regulatory documents.
• Experience overseeing CRO biostatistics and statistical programming in a largely outsourced operating model.
• Strong technical proficiency in R and/or SAS, including the ability to evaluate analyses, simulations, and vendor proposals.
• Working knowledge of CDISC SDTM/ADaM and submission-level statistical deliverables.
• Ability to communicate complex statistical issues clearly to non-statistical stakeholders and senior management.
• Demonstrated ability to operate as a senior individual contributor in a lean, fast-moving, cross-cultural environment and to work effectively at both strategic and detailed technical levels.