Biostatistician II

Location: Basking Ridge

Job Title:

Biostatistician - Clinical Trials (Remote)

Job Description

This role leads complex clinical study work across protocol design, statistical analysis, and interpretation of results, contributing directly to global drug development plans and regulatory submissions. You will act as the primary statistical contact for assigned studies, guide CRO statisticians and programmers, and collaborate with cross‑functional study teams to ensure scientifically sound designs, high‑quality data, and compliant documentation throughout the clinical development lifecycle.

Responsibilities

+ Lead statistical activities for complex clinical studies, including study design, protocol development, CRF review, SAP development, and development of analysis datasets.

+ Ensure the accuracy and validation of statistical analyses, interpret study results, and provide input and review for clinical study reports.

+ Act as the main statistical contact for assigned studies and projects, providing expert statistical guidance to study teams.

+ Collaborate closely with data management to ensure high‑quality, reliable, and analysis‑ready data.

+ Guide CRO programmers and statisticians in preparing analysis files, performing statistical analyses, and adhering to standards and timelines.

+ Contribute to multiple aspects of drug development plans to ensure study designs at each phase are scientifically sound, meet regulatory requirements, and support the intended product profile.

+ Apply strong knowledge of pharmacology, clinical research, and medical terminology to inform study design and interpret clinical outcomes.

+ Identify, investigate, and resolve complex study issues independently, formulating and proposing effective solutions.

+ Develop and execute strategic plans for drug or non‑drug projects, aligning statistical activities with overall development objectives.

+ Prioritize multiple tasks and deliverables, develop clear instructions for vendors, and manage external partners to deliver high‑quality outputs on schedule.

+ Ensure strict adherence to internal and external compliance practices, SOPs, and GMP-related expectations to maintain the integrity of all work.

+ Suggest and implement innovative approaches to improve compliance, documentation standards, and statistical processes.

+ Apply strong document classification and data quality practices, including analyzing metadata, categorizing files, and identifying duplicates or misfiled records.

+ Maintain accurate and compliant documentation, ensuring correct naming conventions, proper filing, and adherence to retention requirements.

+ Communicate statistical concepts, study results, and recommendations clearly to cross‑functional teams and stakeholders, both orally and in writing.

+ Stay current with statistical methodologies, evolving drug development trends, and regulatory expectations, and apply this knowledge to ongoing projects.

Essential Skills

+ Strong background in biostatistics or statistics with direct experience in clinical trial design and analysis.

+ Deep understanding of statistical methodologies relevant to clinical research and drug development.

+ Significant knowledge of pharmacology, clinical research processes, and medical terminology for use in study design and results interpretation.

+ Working knowledge of clinical trial methodologies and regulated environments.

+ Excellent programming skills in SAS and/or R for clinical data analysis and reporting.

+ Working knowledge of specialized statistical software such as nQuery, East, or similar tools used for sample size and trial design.

+ Experience operating within pharmaceutical or clinical research environments with SOP and GMP knowledge, including compliance and documentation standards.

+ Strong document classification and data quality skills, including the ability to analyze metadata, categorize files, and identify duplicates or misfiled records.

+ High attention to detail and a strong compliance mindset, ensuring accurate naming conventions, proper filing, and adherence to retention and documentation requirements.

+ Strong analytical and problem‑solving skills, with the ability to guide lower‑level biostatisticians in…