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Alimentiv

Posted 4 months ago

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Consulting Statistician

AtlantaRemoteFull-time

AI Summary

Statistical expert who designs, analyzes, and interprets clinical study data; advises clients and internal teams on statistical planning, study design, and reporting within regulatory guidelines.

About this role

As a member of Alimentiv’s Statistical Center of Excellence, the Consulting Statistician is responsible for the research, development, and application of innovative biostatistical methods to support clients in clinical study design and implementation. This role advises internal and external clients on statistical planning, study design, data analyses, reporting and interpretation in accordance with project, regulatory and Alimentiv quality standards. Maintains contemporaneous knowledge of statistical methods, industry standards, and regulatory requirements in assigned therapy areas. Provides statistical education and communicates abstract statistical concepts in a manner such that non-statistical colleagues and clients can make informed decisions. Demonstrates thought leadership though contributions to website content and scientific publications and by delivering presentations at conferences or via webinar. Contributes to business development opportunities by meeting with potential clients and contributing to study proposals and capabilities presentations·
Positions available: 1 (remote based, Canada or USA)

Statistical Consulting Services

  • Communicates with clients and internal stakeholders to understand their statistical and clinical needs. Provides recommendations, guidance, and education on statistical concepts. Creates supplementary materials such as slides or reports to assist in communication and understanding of recommendations and concepts. Provides critique of and recommendations for study design after investigating innovative methods, accepted industry standards, and regulatory requirements.
  • Prepares statistical analysis plans and oversee project data collection, management, and analysis, with input from the project team, incorporating details regarding the type of information collected, sample size, randomization procedures, table and listing shells, project statistical policies, protocols, and methodology to be used to appropriately translate scientific questions into statistical hypotheses.
  • Reviews, edits, and assists in preparing statistical sections of study synopses, protocols, reports, publications, or presentations in collaboration with clients and internal stakeholders ensuring statistical analyses adhere to trial, sponsor, organizational and regulatory requirements, and best practices.
  • Advises and consults with various departments internally ensuring that strategies include critical project success factors.
  • Oversees and supports project teams in relevant studies; analyzes implementation gaps and works with relevant stakeholders to close them.

    • Professional Development and Thought Leadership

  • Stays up to date on new innovations in statistical methods, especially in study design relating to chosen or assigned areas of focus.
  • Reviews statistical research papers, learning new statistical techniques and methodologies, and maintaining subject matter expertise.
  • Reviews literature related to clinical research, assigned therapy areas and in the areas of clients’ studies to pair with statistical knowledge to provide guidance that is innovative and in line with the needs and standards.
  • Represents Alimentiv at relevant scientific meetings and congresses and attends trainings relating to statistics, clinical research, and medical areas of interest to continue knowledge growth and expertise.

    • Business Development Support

  • Working in conjunction with the Statistics and Medical Research and Development teams, develops and presents new and novel clinical trial designs and processes and statistical methodologies into publishable and promotable scientific operations and results.
  • Creates materials such as white papers, case studies, and statistical education materials for presentation and posting on Alimentiv websites to foster client relationship development and attract new clients.
  • Leads or supports strategy discussions and development of proposals for Statistical Center of Excellence projects.
  • Provides the proposal lead and functional leads with information necessary to prepare an accurate proposal that meets the strategy parameters.
  • Involved in frequent client meetings/presentations and responsible for transferring knowledge to applicable project team members regarding the proposal/study strategy at the time of a bid defense.

    • Qualifications

  • Candidates should posses a Master's degree and a minimum of 4-6 years of related experience. Advanced degrees in Statistics/Biostats is considered an asset.
  • The ability to communicate abstract concepts
  • Highly refined oral and written communication skills
  • High level of presentation skills

    • Skills

    BiostatisticsClinical Trial DesignConsultingData ManagementData VisualizationPower/sample Size CalculationsProposal DevelopmentPublishingPythonQuality StandardsRRandomization ProceduresRegulatory ComplianceRegulatory SubmissionsSASScientific CommunicationStatistical Analysis PlansStatistical EducationStatistical MethodsStatistical ReportingStudy ProtocolsTables/listings/figures (TLFs)Therapeutic Area Knowledge

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