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.
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...
...Cabinet Finisher Iin GAC St. Louis Unique Skills: The compensation range for this role is $21.25 - $27.88 per hour. Final compensation for this role will be determined by several factors including but not limited to: minimum and preferred qualifications, knowledge...
...Adventures by America is a professional travel services company specializing in leisure... ...individuals to join our team as Remote Travel Agent. In this role, you will assist clients... ...Respond to inquiries through phone, email, and online communication platforms Maintain...
...Primary Purpose: An Instructional Coach will work as a colleague with classroom teachers to support student learning in all content areas. The Instructional Coach will focus on individual and group professional development that will expand and refine the understanding...
...Description Job Description Join a 70+ year family-owned custom cabinetry shop and put your finishing skills to work on high-end, custom-home projects not production-line cabinets. We're hiring immediately for our growing finishing department. The Job Stain, paint...