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Company: Actalent
Location: Raleigh
Posted on: March 18, 2023

Job Description:

Description:Ensures standard operating procedures are followed and that appropriate project documentation is ongoing.Ensures timely, accurate, and complete filing of biostatistics trial documents in accordance with the TMF Master Index, the TMF Plan, SOPs, and any other documented conventions.Supports integrated eTMF workflows for biostatistics trial documents including a quality review of biostatistics trial documents prior to approval and filing.Provides randomization schemes and appropriate documentation. Provides sample size calculations and justification in study protocols.Coordinates with programmers and data management personnel regarding database maintenance, updating, and documentation.Writes and reviews Statistical Analysis Plans (SAPs) and table, figure, and listing (TLFs) shells.Works with the programmers to create and review specifications for SDTM and ADaM datasets.Programs/validates statistical tables and figures with an emphasis on protocol defined endpoints.Provides proper documentation and oversees the work of others who assist in programming/validating.Reviews the define.xml, annotated CRFs, data reviewer guides, and Pinnacle 21 reports.Prepares and reviews statistical reports.Contributes to the statistical methods sections of protocols and/or clinical study reports, assists with statistical interpretation of study data, and verifies information for completeness and consistency.Assists the programmers in developing tools to help automate and simplify work processes within the biometrics area.Interacts with and supports other personnel to fulfill project role and achieve project goals.Skills:Biostatistics, Statistics, Sas, Clinical trial, Clinical research, Sas programming, Statistical analysis, Data, Clinical data, Data analysis, Biometrics, Analysis, Programming, Drug development, Data management, Clinical studies, DesignAdditional Skills & Qualifications:QualificationsMaster's (MS) degree in statistics, biostatistics, mathematics, or related field; at least 2 years of experience as a clinical trial statistician within an academic center, clinical data management organization, pharmaceutical company, or clinical research organization (CRO). Understands clinical research. Learns new IT systems quickly, including eTMF. Ability to multitask, prioritize, negotiate, analyze and solve problems, manage competing priorities, meet timelines, and work independently are required. Excellent communication skills, ability to work within a cross-functional team, and strong attention to detail are expected.Other qualifications include:Knowledge of statistical theory and methods for biomedical researchExperience working on statistical deliverables such as statistical sections of clinical protocols, statistical analysis plans (SAPs), and creation and validation of statistical programsUnderstanding of SDTM and ADaM CDISC standardsPrior experience of collaboration with data management in ensuring quality in data collection, aggregation, and analysisWorking knowledge of SAS. Knowledge of R is a plusSend your resume directly to Gavin at About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Raleigh , Biostatistician, Other , Raleigh, North Carolina

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