Senior Biostatistician - Contractor

2 days ago

Apply Now

Receive Emails with Similar Jobs

Premier Research

WebsiteLinkedInAll Job Openings

Analgesia • CNS/Neuroscience • Rare Disease • Pediatrics • Oncology

1001 - 5000

💰 Venture Round on 2016-10

Description

• Premier Research is looking for a Senior Biostatistician to join our Statistics team. • You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. • Independently utilize your respected expertise to provide statistical consulting. • Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications. • Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents. • Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses. • Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions. • Independently prepare analysis data specifications. • Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS. • Perform quality control of analysis data and TLGs. • Review and provide input in interpreting analysis result to clinical study report.

Requirements

• Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience. • Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms. • Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills. • Detail oriented, well organized with the ability to work on several projects simultaneously. • Excellent team player, collaborative and maintains a positive, results-orientated work environment. • Accountable, dependable and demonstrates strong commitment to the role. • Is customer service focused in approach to work, both internally and externally.