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Are you looking to join a company where your contributions truly matter, and where you’ll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.Senior Biostatistician:Roles & ResponsibilitiesProvides advanced input into statistical sections and overall consistency of clinical study protocolsDevelops and reviews statistical analysis plans (SAP). Determines appropriate analyses for clinical endpoints based on input from the protocol and the clientPerforms senior-level reviews and is responsible for the datasets and outputs of a project. Ensures consistency with the SAP and reviews for correctness and qualityWorks with programming team to provide definitions for analysis/ADaM datasets to be used for final analyses. Develops specifications and reviews datasets based on what is needed for the planned tables, listings and graphs (TLGs)Prepares TLG shells/specifications and programming notes based on SAP and analysis/ADaM datasetsWorks with data management team to review data collection (e.g., CRFs) and helps ensure data quality throughout the clinical trialPerforms and/or coordinates the preparation, execution, reporting and documentation of high-quality statistical analysis according to the SAPProvides high level of support to the programmers and medical writers on all statistical matters according to client requirementsPrepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writersProvides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statisticianGenerates sample size calculations appropriate for the primary endpoint and based on input from the protocolGenerates and reviews randomization schedules per the protocol and randomization specificationsWorks with the project management group to ensure timelines are appropriate given the scope of the projectIs familiar with and stays current with the latest industry practices and updated regulatory guidelinesCommunicates competently and independently with client to coordinate the statistical and programming considerations of the projectDemonstrates strong understanding of ICH guidelines, as applicable to statisticsPractices good internal and external customer serviceRequirementsMaster of Science (in statistics of equivalent) with four (4) plus years relevant work experience or PhD (in statistics of equivalent) with two (2) plus years of relevant years of work experienceStrong knowledge of and experience with SAS (SAS Stat, SAS Base, SAS macros, SAS/ODS, SAS/Graph)Able to be in a hands-on role by digging into data and using SAS to validate datasets and outputsExcellent mathematical and problem solving skillsAdvanced knowledge of the statistical considerations involved in drug development including hands-on experience with clinical trial dataStrong knowledge of study designs and statistical analysis methods (e.g., GLMs, non-parametric methods, survival analysis techniques, general imputation methods, common descriptive stats)Strong familiarity with a variety of clinical data and databases (including EDC systems)Working knowledge of SDTM/ADaM standards (in the absence of ADaM experience, considerable experience working with analysis or derived datasets)At least three (3) years of experience in pharmaceutical industryAbility to coordinate the analytical aspects of multiple projects or clinical trials at the same timeProficiency with MS Office applications (e.g., Word, PowerPoint and Excel)Good interpersonal, oral, and written communication skillsSelf-motivated, hardworking, dependable, and positive team-oriented personalityAbility to communicate effectively and provide clear directions to Statistical ProgrammersPlease consider your application unsuccessful if we do not reach out to you within 14 days of your submission.
