Prepares and maintains statistical analysis plan and coordinate the analyses for study report and other documents and provides programming and validation support of these analyses.
Represents Biostatistics on project/study teams and coordinate/communicates with management and other team members regarding project/study status and timeline update.
Provide statistical leadership in the preparation of PMA submissions and other regulatory documents as needed, and appropriately handle ad hoc data analysis requests and publication/presentation efforts related to the project team.
Reviews and approves the statistical section(s) of clinical study reports or other documents in support of a PMA or other regulatory submissions.
Mentors junior statisticians and work with management in resource allocation and budget/timeline development activities.
Lead the efforts of data analysis for data monitoring committee as needed.
Contributes to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs).
PhD in Statistics/Biostatistics and at least 5 years of clinical trialexperience within the medical device or pharmaceutical industries.
Masters in Statistics/Biostatistics and 8+ years of clinical trialexperience within the medical device, pharmaceutical, biotech industries.
Up-to-date expertise/knowledge in advanced statistical methodologies related to clinical trial designs, statistical modeling and data analyses.
Must possess the ability to work on complex statistical problems, have proficient knowledge of SAS and familiarity with other statistical software packages. Bachelor's degree in related field required.
Must have the ability to clearly and effectively communicate with management, internal stakeholders and external parties, including regulatory authorities, using excellent written and oral communication and organizational skills.
Must have the ability to work both independently and as a part of a project team.
Must have exposure and familiarity with relevant ICH, FDA, and ISO guidelines and guidance documents and be able to search and review relevant medical literature.
Strong motivation to succeed and be able to mentor junior statisticians.