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.
...About the role and team As Apollo's Revenue Manager you'll take ownership of our order-to-cash engine end to end, spanning subscription and usage-based revenue. You'll partner closely with Finance leadership to modernize how we bill, collect, and report, and you'll help...
...produce and the Our Family portfolio of products, to locations in all 50 states. Our braggingly happy team members ranging from bakery managers to order selectors; from IT developers to vice presidents of finance; from HR Business Partners to export specialists ...
...Job Title Social Worker I, Criminal Justice (STATEWIDE) Salary: $71,805 - $77,726 (with potential growth up to $113,243). Employment Type: Full-Time Work Locations: Allegany Anne Arundel Baltimore City Baltimore County Calvert Caroline...
...NUCLEAR RADIOLOGIST BANNER MD ANDERSON CANCER CENTER - PHOENIX, AZ Banner MD Anderson... ...Finishing fellows and experienced physicians are encouraged to apply Have excellent... ...training and oncology experience Nuclear Medicine training and Theranostics experience,...
...Job Title: HVAC Brazer / Copper Tube Assembly Technician Job Description This hands-on manufacturing role focuses on building and installing refrigeration and water piping subassemblies used in commercial HVAC equipment. You will cut, bend, fit, and braze copper...