Get Our FREE Industry eNewsletter

Principal Biostatistician, SCRI Development Innovations Nashville, TN or Remote

Academic Research Jobs

Apply
Location:
Nashville, TN
Posted Date:
8/8/2014
Position Type:
Full time
Job Code:
hec.1516353
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Principal Biostatistician, SCRI Development Innovations Nashville, TN or Remote-25319-1875

Primary Location: United States-Tennessee-Nashville-Sarah Cannon

Job: Other

Schedule: Full-time

Description

Principal Biostatistician

Summary of Key Responsibilities:

Responsible for ensuring that appropriate statistical techniques

are used which guarantee the scientific validity and overall quality of clinical trial results. Perform statistical analysis, contribute statistical input when requested, and represent the Biostatistics function of SCRI to external partners.

Duties and Responsibilities:

Duties include but are not limited to:

  • Act as a lead representative of the biostatistics department on project teams, provide support and guidance on data and statistical-related issues to the teams, attend project team meetings as necessary, and be responsible for the quality, accuracy and timely completion of the assigned tasks

  • Provide statistical input and support related to trial design and in the development of protocol synopses, protocols and CRFs

  • Advise Data Management with respect to database design, validation checks & key data, to ensure that all data required for analysis purposes are captured adequately

  • Coordinate the development of randomization schema

  • Coordinate & develop statistical analysis plans (SAP)

  • Coordinate & perform data review to ensure data are suitable for analysis

  • Work with the programmers to provide definitions, specifications, documentations and review of derived datasets required to produce the planned statistical outputs, including tables, figures and listings

  • Coordinate the production of statistical outputs for various analysis and reporting purposes, and provide statistical review and program validation for each project, to ensure the integrity, adequacy and accuracy of the outputs

  • Provide statistical insight in the interpretation and discussion of study results, and provide statistical contribution to the integrated clinical study reports and publications

  • Maintain & archive program documentation - both electronic & paper - in an appropriate

    manner

  • Keep management abreast of issues and progress on all assigned projects

  • Maintain professional statistical standards by keeping abreast of new developments in statistics, drug development and regulatory guidance through literature review and attendance/participation at workshops and professional meetings

  • Understand and apply regulatory guidelines/developments and industry standards/best practices on statistics and SAS programming

  • Lead or contribute to the development and implementation of internal process improvement initiatives

  • Mentor more junior members of the Biostatistics team on project-related and statistical-related issues

  • Collaborate with all functions to earn their respect as a trusted and value-driven business partner

  • Work collaboratively with SCRI scientists and authoring physicians

  • Work collaboratively with vendors and other external partners

  • Represent SCRI to external partners in a professional manner

  • Provide statistical advice and consultancy within SCRI or by external partners

  • All other duties as assigned

  • Mandatory:

  • Practice and adhere to the Code of Conduct philosophy and Mission and Value Statement

  • During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.

    Knowledge:

  • Strong hands-on experience and knowledge with SAS and other statistical software

  • Strong knowledge in statistics including study design methodologies, categorical data analysis, survival analysis, etc. Experience in the use of modelling and simulation to enhance clinical trial design and decision making would be advantageous.

  • Excellent understanding of clinical research and drug development process, and requirements on regulatory submissions and compliance

  • Familiar with ICH guidelines, regulatory requirements and industry standards (eg CDISC) and awareness of best practices related to statistical and programming activities

    Skills:

  • Excellent teamwork skills placing emphasis on supporting the goals of the group

  • Excellent time/project management and problem solving skills

  • Excellent verbal and written communication skills including presentation skills

    Abilities:

  • Ability to work with within deadlines and according to procedures and rules

  • Ability to manage multiple protocols and participate in multiple clinical project teams simultaneously.
  • Excellent attention to detail

  • Excellent verbal and written communication skills and presentation skills

  • Patient / Customer-focused

  • Values-based

  • Trustworthy and respectful

  • Credible and influential

  • Optimistic and positive

  • Passion for results

  • Attention to details

  • Effective communication and leadership skills with junior level biostatisticians

  • Project management skills

    Qualifications

    Education:

    Minimum Required:

    Master's Degree

    Preferred:

    Doctorate Degree

    Experience:

    Minimum Required:

  • At least 6+ years of biostatistics in a regulated clinical research environment (pharmaceutical /biotechnology / CRO) required

    Preferred:

    Type of Experience-

  • Experience in oncology highly desirable

  • International experience and cross-cultural awareness preferable

  • Experience in interactions/meetings and/or submissions with regulatory authorities (eg FDA,EMA) would be advantageous

    Time - Given the type of experience stated above: >7 years

    Appropriate education may be substituted for partial experience.

Requirements

By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.