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  5. Study Lead Statistician – Centralized Statistical Monitoring (CSM)
  • ID
    #4403073
  • Job type
    Contract
  • Salary
    TBD
  • Source
    Infotree Service Inc
  • Date
    2020-07-20
  • Deadline
    2020-09-18

Study Lead Statistician – Centralized Statistical Monitoring (CSM)

 California, Usca 00000 Usca USA
 
Contract

Vacancy expired!

Job Description

The Study Lead Statistician for Centralized Statistical Monitoring (CSM) will assist in the development of methodologies that will result in the development of software to aid in the evaluation of the integrity of clinical trial data. Working as a member of the Centralized Statistical Monitoring (CSM) team you will be responsible for delivering and enhancing CSM across multiple studies.Basic Job Responsibilities: Design of new algorithms for detection of clinical data quality issues Support Software Development Life Cycle As a member of the cross-functional Centralized Statistical Monitoring (CSM) team responsible for delivering CSM across multiple studies Assist in resource planning for assigned projects Be familiar with all Company’s policies, SOPs and other controlled documents related to activities performed Be familiar with statistical policy and strategy at client Assist with study and systems audits conducted by Company GCA and external bodies Stay abreast of latest developments in the field of statistics in drug development and Centralized Statistical Monitoring

Potential Responsibilities: Contribute to scientific advances in the field within client Promote and communicate statistical awareness and the role of the Centralized Statistical Monitoring, and may contribute to statistical consultancy, training and expert advice within client Lead and/or participate in change / process improvement initiatives within client Perform all duties and responsibilities associated with the Study Lead Statistician role Oversee the work performed by multiple Study Statisticians Participate in external activities (e.g., Industry, academic) Serve as a subject matter expert within a specified field of statistics internally and/or to external collaborators

Requirements: Master’s degree in Statistics/Biostatistics or other subject with high statistical content with at least 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Biostatistics or other subject with high statistical content and 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research Software Development Life Cycle experience Strong ability to apply statistics in the analysis of clinical trials (deriving, analyzing, visualizing, interpreting) Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, that include programming teams Strong understanding of statistical concepts related to the design and conduct of clinical Studies Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia Excellent oral and written English communication skills Strong fundamentals of Project Planning and Project Management Strong SAS programming skills

Preferred Qualifications: Master’s degree in Statistics/Bio-statistics or other subject with high statistical content and at least 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Bio-statistics or other subject with high statistical content and 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research Designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/ Public Health setting in Industry, Government or Academia Authored a protocol, DRT/DMC charter, SAP and/or CSR Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences (study/product team) and at external meetings Development of policies and SOPs Experience in the utilization of Bayesian statistics in clinical trials

Qualifications

Top 3 Must Have Skill Sets:

o Software Development Life Cycle experience (defining, designing, testing, development maintenance)o Strong ability to apply statistics in the analysis of clinical trials / phase trials(deriving, analyzing, visualizing, interpreting)o Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, working with clinical development colleagues in study management, programming and IS

Additional Information

Remote working possible if experienced

Vacancy expired!

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