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Associate Director, Biostatistics
2 months ago
Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries. We are seeking a highly skilled and experienced Associate Director, Biostatistics to join our team in Bridgewater, New Jersey, USA or remotely from a home-based office in the USA.
Key Responsibilities:- Manage clinical trial programs/projects from one or multiple clients, working closely with Directors, Senior Directors, and Executive Directors of Biostatistics, Statistical Operations, or Biometrics.
- Provide day-to-day technical and operational leadership to project teams supporting these programs/projects.
- Coach, mentor, develop, and provide technical review and advice to direct subordinate Biostatisticians and Statistical Programmers.
- Lead statistical and programming teams, interact with clients and/or Everest internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables.
- Ensure sound statistical methodologies in study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting.
- Provide statistical input in protocol design and development, participate in writing trial protocols and research proposals.
- Serve as a principal level Biostatistician, working effectively with interdisciplinary teams to contribute strategically to drug development and commercialization at the study and drug compound/therapeutic areas levels.
- Review and provide input to clinical data management deliverables, including eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan, and Data Management Plan.
- Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs).
- Perform peer review of SAPs and other technical documents written by others.
- Perform hands-on statistical analysis and modeling, maintain expertise in state-of-the-art statistical methodology and regulatory requirements.
- Validate core statistical tables, listings, and figures programmed by Statistical Programmers and/or Biostatisticians, ensuring that core results for each responsible trial are complete and accurate.
- Perform overall quality control (QC) review on statistical deliverables before they are released to clients.
- Review and confirm ADaM dataset specifications, perform QC activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.
- Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, participate in writing abstracts, manuscripts, posters, and presentations.
- Act as a consultant to less experienced Biostatisticians.
- Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.
- Interact with regulatory agencies and support Sponsor in new drug application, participating as a statistical liaison to the regulatory agency on behalf of the Sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency's requirement/expectation.
- Perform statistical and programming resource management, capacity analysis, benchmarking, and generation of performance metrics.
- Participate in the continuous improvement and maintenance of statistical and programming governing documents.
- Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.
- Assist in business development activities, including providing cost estimates of statistical and programming services, participating in generation of project proposals and bid defense meetings, and participating in professional trade shows when required.
- Participate and/or assist in statistical and programming project budget planning, tracking, and reporting.
- Perform tracking of out-of-scope services on assigned projects, provide cost estimates, and draft change orders to existing services work orders.
- A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 10 years' relevant experience or a Master's degree in these fields with at least 13 years' relevant experience.
- Demonstrated exceptional ability and performance.
