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

• 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.

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:

• 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.

• 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…