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.
...CSWS Cathedral Park Performing Arts Collective Program Assistant (St. Johns)Job Title - CSWS Cathedral Park Performing Arts Collective Program Assistant (St. Johns)Department - Moreau CenterTerms and Hours - Approx. 8-12 hrs/wk, Fall & Spring SemesterJob Category - Student...
...Overview GLOBAL PACIFIC SUPPORT is on the lookout for a dynamic Search Engine Optimization (SEO) Specialist to elevate our digital presence.... ..., and make data-driven recommendations to improve our online visibility. Join us in making a significant impact in the digital...
...Job Description Job Description COUNTY CORRECTIONAL POLICE OFFICER DEFINITION: Under supervision during an assigned tour... ...to prevent injuries and maintain security. Learned names, identification numbers, and faces of problem inmates. Briefs oncoming officer...
...NOW HIRING Frac Support / Rig-Up & Rig-Out Crew Montana / Wyoming Area | Local Candidates Get First Offer We are hiring frac support hands for rig-up and rig-out work across the Montana/Wyoming region. This is demanding field work for people who show up ready...
...cool, fast-growing brand that provides computer solutions to residential consumers and small... ...and software fault isolation and repair System repair and upgrades Software... ...Team At Nerdstogo At NerdsToGo, our technicians don't just "go to work." Our business model...