Job Title

Roles and Responsibilities Lead complex projects, programs and submissions, manage client meetings, CRMs, collaborate well with regulatory, PMs and sponsors. Can develop SAPs and iSAPs text and shells with no supervision. Produce and present external company presentations providing industry visibility for the organization; continually suggesting solutions to solve issues in tune with organizational direction. Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments. High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques. Has the ability to apply drug development knowledge during production of complex statistical analyses. Review or create the statistical section(s) of a Sponsor's protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers. Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management. Perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors regarding study design and sample size calculations. Ability to create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams. Understand the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint). Provide support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician. Is familiar with and stays current with the latest industry practices and updated regulatory guidelines. Write blogs and/or white papers for posting on the company website. Requirements Masters in Biostatistics, Statistics discipline or related field, or related experience; PhD preferred. Minimum of 7 years' experience in Biostatistics, Statistics or similar field required. Submission experience (ISS/ISE). Has high level knowledge of drug development as it pertains to biostatistics. Expert knowledge of scientific principles and concepts. Good communication skills and willingness to work with others to clearly understand needs and solve problems. Good organizational skills. High proficiency with MS Office applications. Hands"‘on experience with clinical trial and pharmaceutical development preferred. Excellent problem"‘solving skills. Familiarity with current ISO 9001 and ISO 27001 standards preferred. Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Good understanding of CROs and scientific & clinical data/terminology, and the drug development process. #J-18808-Ljbffr