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Associate Director Biostatistics

Integrated Resources, Inc

Woodcliff Lake, New Jersey

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Analysis Skills, Bayesian Networks, Biostatistics, Biotech and Pharmaceutical, Clinical Research, Clinical Study Publications, Clinical Support, Clinical Trial, Computer Programming, Contract Research Organization (CRO), Data Analysis, Data Management, Data Sets, Drug Development, FDA (Food and Drug Administration), Identify Issues, Information Technology & Information Systems, Interpersonal Skills, Leadership, Multitasking, Neurology, Neuroscience, New Drug Application, Organizational Skills, Phase III Clinical Trials, Problem Solving Skills, Project/Program Management, Publications, R Programming Language, Regulations, Regulatory Requirements, Regulatory Submissions, Rehabilitation Nursing, Risk Management, Standard Operating Procedures (SOP), Statistical Analysis System (SAS), Statistical Modeling, Statistical Programming Languages, Statistics, Statistics Software, Surveillance
LOCATION
Woodcliff Lake, New Jersey
POSTED
3 days ago
Associate Director BiostatisticsIntegrated 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 DescriptionThe 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: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 studiesDeveloping and/or reviewing statistical documents for multiple clinical trials, including SAPs, TLG shells and specification variable derivationDeveloping 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 studiesDeveloping the Data Monitor Committee charter and liaising with independent statisticiansProviding statistical and validation support for analysis datasets, statistical tables, figures and listings. Performing and validating statistical analysis. Reviewing CSRs and performing data interpretationLeading 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 responsesDirecting project team activities to identify biostatistics issues, proposing solutions and providing Biostats support to clinical areasDeveloping and maintaining SOPs, SWPs and work guidelines and other related technical documentsQualifications• At least 6 years of pharmaceutical clinical trial experience (neuroscience experience preferred) with Ph.D. in Biostatistics or StatisticsFamiliarity with clinical trial Phase II-III study design and interim analysis; Regulatory submission experience is a plus.Strong expertise in applying statistical methodsStrong 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 memberKnowledge of FDA and EMA guidance for drug developmentFamiliarity with the SDTM, ADaM, eSUB standards and requirements for regulatory submissions and CSRAbility to handle multiple projects concurrently and within tight timelines.Experience contributing to sensitivity analysis for missing data, longitudinal data analysis and statistical modeling diagnosticsExperience with Bayesian study designs is an added advantageExcellent 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 collaboratorsMust be flexible to work in a dynamic environment where multi-tasking and changing priorities existMust possess strong analytical skills in addition to demonstrated problem solving and risk mitigation skillsRecognized in the profession as a dedicated professional with a strong work ethicMust 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

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Integrated Resources, Inc