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.
Company DescriptionIDEALFORCE has a Contract/potential CTH position available immediately for a Drupal Developer to join our customer in Phoenix, AZ. Please find below additional details about this job. Kindly respond with your most up to date resume if you would like...
...Italian Language Expert is a remote evaluation track for reviewing italian generalist evaluation prompts and responses against AuraOne's quality rubric. Reviewers compare paired outputs, label edge cases, and write the kind of structured feedback the modeling team can...
...Job Overview TLC Nursing Associates, Inc. is seeking an experienced RN Operating Room (OR) for travel assignments . This role involves assisting in surgical procedures... ...and scenic landscapes, will be your home base during this travel nurse assignment. Explore...
...This position may qualify for a sign-on bonus. Responsible for the planning, implementation and directing BHS system core supply chain duties and functions as assigned. Core duties will include a regional category management and site level leadership responsibility...
...safety net hospital with a robust academic affiliation and ongoing partnerships with top New York institutions, is hiring a Chief Medical Officer. This executive leadership role offers an opportunity to shape the future of a dynamic healthcare organization undergoing transformation...