[Next-Generation Sequencing Book]
  • [Photo] Corky Harris • March 23, 2010

    BACKGROUND

    Global Clinical Development is one of the business units under the Health and Civil Services Sector of SRA International. This business unit works as a CRO to assist both pharmaceutical and biotechnology clients in all areas of drug development. These areas include: pre-clinical product development consulting, Phase I - IV clinical trials (including clinical monitoring, trials management, data management, statistics and SAS programming); regulatory affairs and strategic drug development consulting; quality assurance; medical writing; pharmacovigilance; and program management. Therapeutic areas of expertise include: HIV/AIDS, oncology, diabetes, CNS, sexual dysfunction and vaccines.

    RESPONSIBILITIES

    We are currently searching for a Statistics Manager / Senior Statistician to join our team. This Statistician performs and co-ordinates statistical activities for Biometrics operations, while ensuring that all services are performed to the highest standards and within required timeframes and budgets. The Statistics Manager / Sr. Statistician will be the main statistical contact for customers or Clinical Project Manager(s) for Biometrics projects; and may also take part in various business development opportunities. The Statistics Manager will also line-manage 2 employees and could possibly oversee contract staff as needed (prior line management experience not required). This position will be based from our Durham, NC office.

    Duties:
    • Writes statistical analysis plans and constructs shell tables
    • Advises on study and protocol design and performs sample size calculations
    • Produces safety reports and produces tables, listings and figures of data for reports (e.g. Clinical Study Reports, Statistical Reports, etc.)
    • Reviews documents that have an impact on statistics and SAS programming
    • Provides statistical consultancy for clients
    • If required, performs SAS programming for efficacy and safety tables, listings, figures and analyses
    • Performs QC of tables, listings, figures and analyses
    • Performs statistical analysis and study reporting functions
    • Writes statistical reports
    • Lead and participate in presentations to clients, sites and cross-functional groups
    • May solely coordinate/lead activities/project management large stand-alone projects within the Biometrics department
    • Represents Statistics in client-facing meetings; helps seek new statistics and SAS programming business opportunities
    • Reviews cost estimates and assumptions with the customer post-study award, and prior to or during the finalization of the contract
    • Participates in the training and orientation of new staff including coaching of any statistics and SAS programming staff
    • Mentors other Senior Statisticians and Statisticians; may line-manage permanent or contract statistician(s)

    REQUIREMENTS

    • Requires at least a Bachelors degree, preferably in the area of Mathematics or Statistics; and 3 - 5 years clinical research statistical experience.
    • Requires a strong working knowledge of SAS
    • High level of proficiency in the full range of essential statistics and SAS programming tasks
    • Strong working knowledge of clinical trials and statistician role in the clinical trials process understanding of the applicability of ICH GCP to statistics and SAS programming functions
    • Strong leadership capabilities and delegation abilities; as well as excellent people management skills. Direct line management experience preferred by not required.
    • Excellent analytical, organizational and problem-solving abilities, and ability to prioritize multiple tasks
    • Excellent attention to detail
    • Ability to successfully work on multiple projects and prioritize daily tasks and responsibilities
    • Well-developed interpersonal skills and ability to function as part of a multi-disciplinary team
    • Highly effective communication skills, both written and verbal
    • Knowledge of Microsoft Word, Excel and PowerPoint
    • Conversant in the management of project scope and in working with staff and customers to ensure budgets and timelines are defined and maintained
    LOCALE: Durham, NC

    HOW TO APPLY

    Please visit our website at: http://www.sra.com/careers/ to apply.

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