Director, Biostatistics

Description :

The Director, Biostatistics reports directly to the VP of Biometrics and is part of the Biometrics department. This role provides strategic and hands-on biostatistical leadership across clinical development programs, including study design input, statistical methodology, analysis planning, and interpretation of clinical trial results. The Director leads the development of Statistical Analysis Plans (SAPs), oversees statistical programming and quality control for analysis datasets, tables, figures, and listings (TFLs), and supports internal decision-making through rigorous exploratory and inferential analyses. In close collaboration with Clinical, Medical, Regulatory, and Data Management, the role ensures analyses are scientifically sound, traceable, and aligned with applicable guidance (e.g., ICH E9, ICH-GCP) to enable timely clinical study reporting and regulatory submissions.

Location : WARREN NJ - 3 + days a week

Salary Range : 185-215K

Mission:

• Provide biostatistical leadership to support clinical development strategy, protocol design, and endpoint selection.
• Lead analysis planning and execution, including SAP development, interim/ad hoc analyses, and interpretation of study results.
• Oversee statistical programming deliverables (analysis datasets and TFLs) and ensure fit-for-purpose QC and traceability.
• Apply modern statistical methods and data science approaches to generate insights and support evidence generation.
• Partner cross-functionally to deliver high-quality clinical study reports and support regulatory submissions with defensible statistical outputs.

Key Responsibilities:

Within the Biometrics department, you will ensure, in an international context, the biostatistics and statistical programming activities for clinical studies, with a strong focus on data analysis, interpretation, and clear communication of results. Your main missions include:
1/ Biostatistics Leadership, Statistical Analysis, and Programming Oversight

• Provide statistical input to protocols, including study design options, randomization/stratification, sample size, estimands, and endpoint strategy.
• Lead the development, review, and finalization of Statistical Analysis Plans (SAPs), including handling of missing data, multiplicity, interim analyses, and sensitivity analyses.
• Oversee statistical programming for analysis datasets and TFLs, ensuring adherence to standards (e.g., CDISC ADaM/SDTM as applicable) and internal conventions.
• Plan and execute primary, secondary, and exploratory analyses; interpret results and communicate statistical conclusions to cross-functional stakeholders.
• Ensure analysis readiness by partnering with Data Management on data review, query strategy, and data cleaning priorities (without owning operational database build activities).
• Design and implement statistical QC approaches (independent programming, review checklists, and verification of key endpoints) to ensure accurate and reproducible results.
• Contribute to clinical study reports, publications, and regulatory submission content by drafting/reviewing statistical methods and results sections and providing supporting outputs.
• Drive methodological excellence and continuous improvement (e.g., reusable code, templates, and automation) to increase efficiency and consistency across studies.
• Establish and maintain biostatistics/statistical programming work instructions, templates, and best practices aligned with regulatory expectations.
• Apply data visualization and exploratory analytics to support trial conduct decisions, signal detection in efficacy/safety trends, and communication of results.
• Support integration of safety analyses with clinical development needs (e.g., AE summaries and risk-benefit interpretation) in collaboration with Pharmacovigilance and Medical.

2/ Interaction and Collaboration

• Serve as the primary biostatistics partner on study teams, contributing to trial strategy, decision points, and interpretation of emerging data.
• Lead or facilitate cross-functional discussions with Clinical Operations, Data Management, Medical, and Regulatory on analysis requirements, data review strategy, and reporting timelines.
• Oversee external statistical programming/analysis vendors as needed, ensuring quality, timely delivery, and alignment with the SAP and standards

Qualifications:

• Advanced degree (MS or PhD preferred) in biostatistics, statistics, or a related quantitative discipline.
• Minimum 7 years of professional experience in Biostatistics and/or Statistical Programming within Clinical Research (CRO, Pharmaceutical, or Biotech), with demonstrated leadership of analysis deliverables and cross-functional decision support.
• Strong command of biostatistical principles for clinical trials, including study design, estimation, hypothesis testing, and interpretation.
• Strong ability to partner with Data Management to translate protocol and SAP requirements into EDC design (e.g., CRF specifications, edit checks, controlled terminology) to ensure high-quality, analysis-ready data capture.
• Demonstrated experience authoring/reviewing SAPs and delivering analysis outputs (TFLs) for clinical study reports and/or submissions.
• Experience with advanced and/or applied statistical methods (e.g., longitudinal models, time-to-event, categorical data, Bayesian or causal methods) appropriate to the program needs.
• Working knowledge of CDISC standards (SDTM/ADaM) and traceability expectations to support analysis and regulatory readiness.
• Expertise in statistical programming (SAS required; R and/or Python desirable) and the ability to review and QC complex analysis code.
• Strong understanding of relevant regulatory guidance and documentation expectations for statistical methods and reporting (e.g., ICH E9/E3 and related addenda).
• Ability to translate scientific questions into analysis approaches, clearly communicate assumptions/limitations, and defend statistical choices.
• Dynamic, rigorous, and collaborative, with excellent stakeholder management, communication, and scientific writing skills.
• Comfortable working in a matrix and international environment, influencing across functions to drive timely analysis decisions.
• Excellent written and oral English.
• Experience leading teams and projects, including mentoring statisticians/programmers and managing deliverables across multiple studies.

Behavioral skills:

• Curiosity: Keep on exploring uncharted territories. Always ask "why?" and more importantly "why not?",
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.

Department Medical Locations US - Warren, NJ Remote status Hybrid