Associate Director Biostatistics

Integrated Resources INC irionline.com Open · verified Oct 24, 2026

On-site Woodcliff Lake Full-time Director Data Science

At a glance

Director-level Data Science role at Integrated Resources INC. Woodcliff Lake · full-time · no salary stated · we estimate $192,500–$255,000 across the United States.

Estimated pay

Integrated Resources INC has not published a salary for this role. The figure below is our estimate, not theirs.

$192,500 – $255,000

What the middle half of lead data science roles in the United States paid, among postings that did state a salary.

Worked out from 129 postings that stated pay, median $218,500. Last updated Oct 23, 2026.

RoleData Science

SeniorityDirector

LocationWoodcliff Lake

WorkplaceOn-site

EmploymentFull-time

PostedJan 18, 2017 · 9y ago

Role brief

dataroles summary, based on the employer's posting.

What you'll do

Shape clinical study designs by reviewing protocols with clinicians, including sample size, analysis approach and study timing
Prepare or review trial plans, table shells and variable definitions, then monitor data quality and assess missing-data risks
Support statistical datasets and outputs, validate analyses, interpret results and review clinical study reports
Lead statistical contributions to regulatory documents and health-authority responses, including any follow-up analyses
Guide project teams on biostatistics issues and maintain procedures, work practices and technical guidance

What you bring

A Ph.D. in biostatistics or statistics and at least six years in pharmaceutical clinical trials
Strong SAS programming and practical command of statistical methods
Knowledge of Phase II and III trial design, interim analysis, and FDA and EMA development guidance
Experience with missing-data sensitivity work, longitudinal analysis and statistical modeling diagnostics

Who this fits

This suits an experienced biostatistician ready to lead clinical study work with minimal supervision and manage several projects amid shifting priorities. The position is onsite in Woodcliff Lake and focuses on Phase III neurology studies; neuroscience experience is preferred.

From the employer

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

JOB DESCRIPTION:
The Associate Director, Biostatistics - Neuroscience will be expected to work with minimal supervision, serving as a lead biostatistician for clinical studies and projects. The incumbent will be accountable for all statistics related activities throughout drug development from study design to regulatory filings and publications. The immediate need is to support Phase III studies within the Neurology Business Group.

Responsibilities include but are not limited to:
1. Reviewing whole protocols and interfacing with clinicians and other functions to understand study requirements and design study elements including sample size calculations, analysis methods, study duration, etc. for multiple studies
2. Developing and/or reviewing statistical documents for multiple clinical trials, including SAPs, TLG shells and specification variable derivation
3. Developing Study Quality Surveillance Plan and monitoring study conduct to proactively address issues to ensure high quality study data. Conducting sensitivity analysis that addresses missing data issues in longitudinal studies
4. Developing the Data Monitor Committee charter and liaising with independent statisticians
5. Providing statistical and validation support for analysis datasets, statistical tables, figures and listings. Performing and validating statistical analysis. Reviewing CSRs and performing data interpretation.
6. Leading preparation of inputs for regulatory documents and ensuring readiness for meetings with health authorities. Leading preparation of responses to health authorities and identification and execution of new analysis required for responses
7. Directing project team activities to identify biostatistics issues, proposing solutions and providing Biostats support to clinical areas
8. Developing and maintaining SOPs, SWPs and work guidelines and other related technical documents

Job Qualifications

• At least 6 years of pharmaceutical clinical trial experience (neuroscience experience preferred) with Ph.D. in Biostatistics or Statistics Familiarity with clinical trial Phase II-III study design and interim analysis; • • • Regulatory submission experience is a plus.
• Strong expertise in applying statistical methods
• Strong programming skills in SAS.
• Familiarity with statistical software such as EaSt, nQuery, Splus, R and others.
• Participation in NDA submission activities as a key stat team member
• Knowledge of FDA and EMA guidance for drug development
• Familiarity with the SDTM, ADaM, eSUB standards and requirements for regulatory submissions and CSR
• Ability to handle multiple projects concurrently and within tight timelines.
• Experience contributing to sensitivity analysis for missing data, longitudinal data analysis and statistical modeling diagnostics
• Experience with Bayesian study designs is an added advantage
• Excellent interpersonal skills in project management, collaboration and communication to leadership, Study Directors, Data Management, Statistical Programming and other clinical development team members, colleagues, CROs, and external collaborators
• Must be flexible to work in a dynamic environment where multi-tasking and changing priorities exist
• Must possess strong analytical skills in addition to demonstrated problem solving and risk mitigation skills
• Recognized in the profession as a dedicated professional with a strong work ethic
• Must be a self-sufficient, highly motivated, highly organized, and proactive individual who is a quick learner.
• Strong desire to be an independent project leader with initiative, maturity and depth that are required for the complexities associated with drug development