Senior Biostatistician

Proclinical is seeking a Senior Biostatistician for a leading CRO located in Durham, NC. As the Senior Biostatistician, you will communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. As well as interpret analyses and write statistical sections of study reports

Job responsibilities:

• Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution.
• Datasets: Writes and maintains programming specifications. Programs assigned datasets to industry standards. Handles dataset derivations and assignment.
• Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Programs TLFs, maximizes programming efficiency with use of tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced.
• Timelines: Plans and documents timelines, forecasts resource needs, suggests work may be out of scope.
• Financials: Shares accountability (with resource managers) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Responsible for sharing budget expectations with the team. Raises concerns to manager if new work or rework appears to be out of scope. Understands 'scope of work' and has an awareness of contract and budget assumptions.
• Protocol: Authors or performs quality control (QC) review of the statistical section of a protocol (making best possible use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods).
• Proposals: May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP). May be expected to present at bid defenses.
• Clinical Study Report (CSR): Reviews or drafts CSR or statistical report.
• Customer: On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients.
• Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration.

Skills and Requirements:

• Bachelor's Degree Biostatistics or related field and 3 - 5 years relevant experience Req OrMaster's Degree Biostatistics or related field and 3-5 years relevant experience Req Or Ph.D. Biostatistics or related field and 1 year relevant experience Req
• Typically requires 3-5 years of prior relevant experience, or equivalent combination of education, training and experience.
• Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention and accuracy with details.
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Familiarity with moderately complex statistical methods that apply to applicable clinical trials.
• Strong working knowledge of SAS computing package.
• Ability to solve moderately complex problems.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium CDISC/ADaM).

If you are having difficulty in applying or if you have any questions, please contact Hunter Lux at (+1) 213-294-2997 or h.lux@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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