Principal Biostatistician

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Irfa******

  • Germany 
  • Last Update: 18.05.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Berlin, DE
Country
Germany

Category


Research & Development (R&D)

Description


Roles And Responsibilities

    • Provide scientific/statistical insight in addressing questions from clients and propose novel solutions to technical issues
    • Interact with relevant stakeholders to ensure that appropriate statistical methods are adequately and consistently applied in all scientific and regulatory documents, presentations, and publications
    • Oversee 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.

Requirements

  • PhD 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 Level

Associate

Industry

    • Research

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