Advanced Group

  • Biostatistics Director

    Job Locations US-Nationwide
    Req No.
    2018-9782
    Type
    Regular Full-Time
    Client
    Advanced Clinical
  • Overview

    Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.

     

    A Director, Biostatistics is responsible for overseeing all biostatistics and SAS programming activities for Advanced Clinical. He/she is also responsible for department level revenue, forecasting and reporting. The Director selects qualified staff, trains them on Advanced Clinical procedures and contributes to each Biostatistics’ staff member’s professional growth and development.

    Responsibilities

    Managerial Responsibilities

    • Train, mentor, monitor, and supervise the biostatistics and SAS programming teams
    • Coordinate teams and assignments of resources across projects and ensure all projects stay on target
    • Ensure overall quality and quantity of biostatistics and SAS programming deliverables
    • Conduct performance evaluations for direct reports, including guidance toward reaching organizational and career goals
    • Inform the Executive Vice President, CRO Operations of project status and employee issues
    • Oversee monthly revenue reporting related to statistical project deliverables
    • Prepare monthly billing reports for biostatistics and SAS programming activities
    • Responsible for P&L management of the statistics department inclusive of the development of the annual budget
    • Understand the Advanced Clinical (AC) overall financial plan and our contribution to and support of AC’s overall financial goals
    • Maximize productivity of direct reports to exceed AC budget goals
    • Write training and establish training programs for new processes
    • Work as a member of an integrated Biometrics team to develop strategies, identify possible improvements to current processes, develop new processes as needed, and speed delivery of final reports to clients
    • Identify possible improvements to current processes, determine new processes that are need, and initiate a plan to improve or develop processes
    • Other global management responsibilities as requested by the Executive Vice President, CRO Operations
    • Create, revise and review Standard Operating Procedures (SOPs) to recognize and prevent potential regulatory issues
    • Assist with RFP/RFI completion and attend sales meetings as requested by Business Development

    Statistical Responsibilities

    • Apply knowledge of statistics and drug development to fulfill primary duties
    • Implement and support CDISC, ICH, and other regulatory standards
    • Review protocols, CRFs, and database structures
    • Prepare, review, and approve statistical analysis plans to ensure that appropriate statistical analyses are proposed and implemented
    • Provide statistical support for Independent Data Monitoring Committees and interim analyses
    • Ensure the accuracy, quality, and appropriateness of the statistical tables, listings, graphs, and derived datasets for Clinical Study Reports and for other regulatory filings, including IND annual reports and Integrated Summaries of Safety and Efficacy
    • Effectively communicate statistical concepts and arguments to colleagues, clients, and regulatory agencies

    Additional Responsibilities

    • Participates in the management team responsibilities as assigned by the Vice President, Biometrics or designee

    Qualifications

    The ideal candidate should have an advanced degree (MS or PhD) in Statistics or a closely related filed, with a minimum of 8 years experience in pharmaceutical development and SAS programming for statistical analysis, and a minimum of 2 years of management experience in a pharmaceutical company or CRO.  Candidate must have experience in clinical trial design and be familiar with regulatory requirements.  Excellent oral and written communication skills, project and personnel management skills, and organizational skills are required.

     

    Minimum Training Requirements

    • The below list includes the general training subject, and not necessarily the exact name of the training course obtained.
    • Applicable Standard Operating Procedures
    • Good Clinical Practices (21 CFR; Guidance Documents including ICH Guidelines)
    • Drug Development and Approval Process

    What’s in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:

    Our Culture: https://careers.advancedgroup.com/embrace-our-culture

    Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential

    Community Programs: https://careers.advancedgroup.com/unleash-your-passion

    For a complete list of all of our job openings, please visit Advanced Group’s career site here.

     

    It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.


    This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job.  If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

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