Principal Biostatistician

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Irfa******

  • Germany 
  • Last Update: 14.06.2019 at 12:54

Job Type
Full Time
Start
Jun , 2019
Duration
6 Month
Place
Berlin, DE
Country
Germany

Category


Research Positions

Description


Roles And Responsibilities Provide scientific/statistical insight in addressing questions from clients and propose novel solutions to technical issuesInteract with relevant stakeholders to ensure that appropriate statistical methods are adequately and consistently applied in all scientific and regulatory documents, presentations, and publicationsOversee design and execution of statistical methods (SAP), statistical analyses, and results (e.g., summary sections for clinical study reports (CSR))Review and approve key results and statistical conclusions.Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package.Can oversee statistical deliverables such as they are consistently compliant, in timing and quality, with SOPs and departmental standards.Performs senior-level reviews and is responsible for the datasets and outputs of a project. Ensures consistency with the SAP and reviews for correctness and quality.Responsible for the statistical considerations in FDA submissions for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), including but not limited to ISS/ISE SAP, data integration plan and oversight of all integrated analyses.Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements.Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers.Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.Generates sample size calculations appropriate for the primary endpoint and based on input from the protocol.Generates and reviews randomization schedules per the protocol and randomization specifications.Works with the project management group to ensure timelines are appropriate given the scope of the project.Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.Communicates competently and independently with client to coordinate the statistical and programming considerations of the project.Demonstrates strong understanding of ICH guidelines, as applicable to statistics.RequirementsPhD in statistics with a minimum of 5 years of experience or MS in statistics or related field with 12 years of experience preferred.Strong knowledge of study designs and statistical analysis methods (e.g., generalized linear and nonlinear models for correlated data, survival analysis, general imputation methods, multiplicity testing).Experience with writing statistical sections of protocols. Experience with statistical methodologies and software for adaptive designs.Excellent mathematical and problem-solving skills.Hands-on experience as lead statistician or senior oversight for at least 2 NDA submissions (both ISS and ISE).Ability to coordinate the analytical aspects of multiple projects at the same time.Good interpersonal, oral, and written communication skills.Self-motivated, hardworking, dependable, and positive team-oriented personality.Knowledge of and experience with SAS.Seniority LevelAssociateIndustryResearchBiotechnologyPharmaceuticalsEmployment TypeFull-timeJob FunctionsResearchAnalystInformation Technology

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