Leading CRO hiring multiple permanent Senior or Principal Biostatisticians, onsite or remote thru United States

Principal Biostatistician

Overview:

Designs, plans, and executes biostatistical components of clinical trials. Uses sound statistical methodology to conduct studies, prepares the statistical components of protocols, and is responsible for the statistical components of reports.

Responsibilities:

  •  Serves as the lead biostatistician on programs of studies or submissions, or on simple to complex individual studies.
    •    Serves as an independent reporting statistician on data monitoring committees.
    •    Develops statistical analysis plans and reporting specifications for simple to complex clinical studies.
    •    Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
    •    Performs senior review of TFLs and statistical analysis plans.
    •    Provides significant input in the development and review of CRFs, edit specifications, and critical variable lists.
    •    Performs lead review of TFLs and derived datasets for clinical studies.
    •    Contributes to clinical study protocols and clinical study reports.
    •    Reviews simple to complex randomization specifications and dummy randomization schemes.
    •    Trains and mentors new or junior statisticians on statistical methods and PRA procedures.
    •    Provides statistical training at monthly seminars.
    •    Participates in bid defense meetings.

Qualifications:

8 years of biostatistical experience

Master’s degree in statistics or biostatistics

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 Sr Principal Biostatistician    

Overview:  

  •    Serves as the lead biostatistician on programs of studies or submissions, or on simple to complex individual studies.
    •    Serves as an independent reporting statistician on data monitoring committees.
    •    Develops statistical analysis plans and reporting specifications for simple to complex clinical studies.
    •    Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
    •    Performs senior review of TFLs and statistical analysis plans.
    •    Provides significant input in the development and review of CRFs, edit specifications, and critical variable lists.
    •    Performs lead review of TFLs and derived datasets for clinical studies.
    •    Contributes to clinical study protocols and clinical study reports.
    •    Reviews simple to complex randomization specifications and dummy randomization schemes.
    •    Trains and mentors new or junior statisticians on statistical methods and PRA procedures.
    •    Provides statistical training at monthly seminars.
    •    Provides statistical consultancy to our clients.
    •    Serves as a technical expert and presents at scientific conferences.
    •    Participates in bid defense meetings.
    •    Represents our clients regarding statistical issues at regulatory meetings.

    Problem Solving & Analysis;

  •  Problems are unclearly defined and sufficient information may not be available.  Requires conceptual thinking to understand complex issues and their implications.   Solutions may need to be devised based on limited information.  Implementation of solutions often requires a longer time horizon. Solutions must take into consideration multiple perspectives and future implications.

Supervision Given/Received:

Adapts style and uses persuasion in delivering messages.  Issues may be complex or audience perspectives may be divergent or information may be non-routine in nature.

Experience:   12 years of biostatistical experience

Applied Knowledge & Skills:  
•    Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures, and good programming practices.
•    Demonstrates ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials.
•    Displays excellent communication skills with demonstrated leadership ability.
•    Shows capability in creating strong working relationships with clients.

Impact:    Contributes to the achievement of goals through personal effort and influence over others in department. Impact is limited to achievement of short-medium term achievement of goals.

Education:    Master’s degree in statistics or biostatistics