Senior Statistician

  • Remote, Remote, Canada
  • Full-time

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 1,700 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

PSI Statisticians are responsible for statistical methodology and statistical analysis of assigned clinical studies.   They liaise with PSI project teams and business partners globally on statistics project-related matters.

    Job Description

    Position Overview: 
    Reporting to the Director of Biostatistics, the Senior Statistician is an integral part of our team here at PSI. If you have experience in clinical research, understand SAS programming principles and concepts, and have knowledge of statistical methods, apply today! 

    Canada Remote Position

    Primary responsibilities:

    • Leading all biostatistics activities related to clinical trials
    • Communicating with project teams, clients and vendors on statistical questions
    • Develop and review statistical sections of protocols, including sample size calculations
    • Develop of statistical analysis plans
    • Develop and document analysis database structures (i.e. SAS analysis data set structures)
    • Develop SAS program requirements and specifications
    • Review and ensure quality control of statistical deliverables (tables, listings, figures, etc.)
    • Perform statistical analysis and report results
    • Provide consultation on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products
    • Liaise with Data Management on statistical questions, including coordination of data transfers from Data Management to Statistics
    • Participate in bid defense meetings and kick-off meetings
    • Conduct  project-specific and general training of statisticians and SAS programmers

    Corporate/Departmental Assignments:

    • Participation in bid defense meetings
    • Participation in kick-off meetings
    • Communication line for project teams, including statisticians and SAS Programmers
    • Communication line for customer on statistical questions
    • Communication line for vendors on statistical questions

    Training:

    • Conduct of project-specific training of statisticians and SAS programmers
    • Coaching and training of statisticians (non-project-related)
    • Preparation and delivery of presentations at investigators' meetings

    Quality Assurance:

    • Preparation for and attendance at internal and third-party study audits pertinent to Statistics
    • Preparation of the answers to the internal/external audits findings/recommendations, and follow-up on and resolution of audit findings
    • Participation in the development of guidelines, procedures and other Quality Systems Documents (QSDs) pertinent to activities of the Biostatistics department  

    Qualifications

    • MSc in Statistics or equivalent
    • At least 5 years of industry experience in clinical research
    • At least 5 years of industry experience in biostatistics
    • At least 5 years of experience in SAS programming
    • Expert knowledge and understanding of  statistical principles, concepts, methods, and standards used in clinical research
    • Ability to apply a range of advanced statistical techniques, analyze, interpret, and draw conclusions from complex statistical information
    • Strong ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
    • Strong ability to represent biostatistics in bid defenses
    • Strong knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
    • Presentation and communication skills
    • Analytical, organizational and time management skills
    • Advanced knowledge of SAS software
    • Advanced knowledge of CDISC ADaM IG 1.0 or later, define 1-0-0.xml and define 2-0-0.xml specifications
    • Knowledge of CDISC SDTM IG 3.1.3 or later; nQuery Advisor software is a plus

    Additional Information

    All your information will be kept confidential according to EEO guidelines.

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