Job-ID32132087Reference26-00454 Job Description: The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. Responsibilities: Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc. Review CRF, database design, and edit check specs. Review study quality surveillance plan and monitor study conduct. Prepare and/or review SAP, TFL shells and specifications for variable derivation. Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables. Provide statistical and validation support for statistical analysis, analysis datasets and TFL. Review study report, manuscripts and other documents related to statistics. Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents. Perform other ad-hoc statistical activities as needed. Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming. Participates in monitoring CRO activities and reviewing CRO deliverables Other duties as assigned. Requirements: Ph.D or MS in Statistics or Biostatistics. Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience. Excellent knowledge of SAS computer package. Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines. Excellent organizational skills, time management, and ability to meet established deadlines. Excellent communication and interpersonal skills to effectively interface with others. Ability to work independently and problem-solve. Ability to provide leadership for the CRO statisticians and statistical programmers.
...Cultural Studies, Political Science, Sociology, English, History, Education, Psychology, or Art.Sensitivity to and understanding of the... ...in the intersections of historically underserved populations in higher education.Experience teaching courses in an Ethnic Studies...
A major retail company is seeking an Asset Protection Specialist responsible for preventing financial loss from theft and fraud. The role involves using tools to monitor security, preparing detailed reports on incidents, and promoting a culture of loss prevention. The...
...for this company as it allowed me to have flexible hours and competitive pay. I was able to use my caregiving skills to assist senior citizens in their private homes." Additional caregiver testimonials are available on our website. What Sets This Role Apart...
...Job Description Job Description Join Galore Creative as an Entry-Level AI Content Writer and Ignite Your Career in the Exciting Intersection of AI and Content Creation! At Galore Creative, we're not just embracing the future; we're creating it. Our dedicated team...
...and looking for an entry-level job with paid training? We are hiring Entry-Level Customer Service Representatives to join our growing... ...learn, gain experience, develop professionally, and grow within a team environment . Apply today for immediate consideration!...