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The Associate Director, Clinical Pharmacology, will be responsible and accountable to lead and execute clinical pharmacology strategies and activities for assigned programs and studies from early through late-stage clinical development and approval, including post marketing activities, and collaborate cross-functional stakeholders including research, DMPK, translational medicine, clinical development, clinical operation, biometrics, regulatory, CMC, and project management.
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Reporting to the VP of Biometrics, the Director/Sr. Director, Clinical Data Management is responsible for all clinical data management activities related to the effective planning and timely delivery of complete, high quality and reliable clinical trial data.
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Experience with advanced knowledge of psychometrics, econometrics, and biometrics such as validation of health measurement scales, longitudinal data analysis, missing data methods, multiple comparisons techniques, cost-effectiveness analysis, generalized linear models, meta-analysis, real-world data analysis, and conjoint analysis.
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Plan, organize, and execute biometrics activities associated with all regulatory submissions (pre-IND, IND, NDAs/BLAs, post-marketing submission), for example, statistical analysis plans, analysis specifications for clinical trial documents and reports, protocols, investigator brochures, as well as preparation of submission data packages compliant with regulatory standards; Review and analyze safety reporting, perform biomarker analyses and other aspects of clinical trial monitoring.
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Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines. This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs.
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Lead and/or author development of new procedures and process improvement (e.g., development of statistical standards such as SAPs, outputs; data sharing procedures for internal and external audiences; data QC prior to release) to meet the needs of an evolving Biometrics Department.
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Collaborate effectively with Clinical Development, Biometrics, Clinical Operations, Regulatory Affairs, Clinical/Translational Pharmacology, Pharmacovigilance, Quality, and external stakeholders as applicable.
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Ph. D. in statistics (or closely related field e.g. medical statistics, biometrics, medical informatics, biopharmaceutical statistics) with 2 years biopharmaceutical industry experience as a biostatistician or a Master's degree in a relevant statistics field and 4 years industry experience (as a biostatistician) in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations (title commensurate with experience.
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Qualifications 5+ years of related experience, including 3 years of relevant industry experience, preferably in data services (data management and biometrics) or a clinical research environment Knowledge of and experience in selling biometrics, regulatory submissions, and regulatory operations will be a distinct advantage.
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Senior Director, Biometrics Team Leader- Late Oncology Hematology ensure Biometrics input and support for drug projects in a clinical development program across a business unit. The extensive experience in the pharmaceutical industry to independently lead a biometrics team to deliver project and/or technical level activities related to design, delivery and interpretation, high level internal governance committees and/or regulatory submissions.
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Represent the biometrics functions on cross-functional and program teams and make strategic contributions to the clinical development plan (CDP) Represent the biometrics functions on cross-functional and program teams and make strategic contributions to the clinical development plan (CDP.
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Acceptable: In lieu of above experience requirement, a combination of other experiences including, but not limited to preclinical research, biometrics clinical supervision, clinical study management, clinical monitoring, and clinical project management may be considered.
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Job Overview: The Senior Manager/Associate Director, Biostatistics will lead statistical analyses for early development of clinical trials, support investigators and researchers on experimental design, and collaborate closely with internal teams while reporting to the Head of Biometrics.
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The ideal candidate must be able to lead a Biometrics team comprising biostatisticians and statistical programmers and excel as a hands-on innovative biostatistician. Experience in managing a Biostatistics or Biometrics team and overall resource planning.
$216,000 - $270,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Acting as a senior member of the Development Leadership Team, the VP of Biometrics will also interact with global Health Authorities, as well as our partner contract research organizations (CRO.
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biometrics job in Cambridge, MA
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