Associate Director Biostatistics

Job description

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 Regards, Sukhpreet Basra Clinical Recruiter “Talent Magnet” Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I Direct:732-429-1921 (Tel) 732-549-2030*241 | (F) 732-549-5549 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.