Senior Statistician (US/Remote

Company: Worldwide Clinical Trials, LLC
Location: California
Posted on: February 23, 2021

Job Description:

Requisition Number 1866 Employment Type : Regular We're a global, mid-size CRO that pushes boundaries, innovates and invents - because the path to a cure for the world's most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way. The Senior Biostatistician independently manages statistical project support and provides expert statistical consultancy across the stats function. RESPONSIBILITIES:

• Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met by expert and timely statistical consultancy and support.
• Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology and writing statistical analysis plans.
• Provide project support to the statistics reporting process through the specification/review of tables, figures and listings shells, writing/review of derived dataset specifications and the formatting of report documents and tabulations.
• Develop, test and run SAS programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings, and their validation.
• Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation.
• Provide support for the bidding process, including contribution to budget review, proposals, and bid defense meetings.
• Maintain knowledge in design consultancy and analysis methodology, statistical software packages (e.g. SAS and nQuery) and regulatory guidance documents e.g ICH, FDA, and CPMP points to consider. OTHER SKILLS AND ABILITIES:
  • Hands-on expert level project statistician experienced in providing statistical leadership to projects.
  • Design and analysis consultancy skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change. REQUIREMENTS:
    • Educated to degree level in mathematics, statistics or another subject with a strong statistical component. Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability. --Worldwide Clinical Trials does not accept unsolicited resumes from 3rd party vendors We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.

Keywords: Worldwide Clinical Trials, LLC, Columbia , Senior Statistician (US/Remote, Other , California, Missouri