Senior Biostatistician

Do you want more than just another job? Are you ready to team up with an organization that values your contributions? Then Hired by Matrix is for you Working with some of the US’ premier companies, we excel at connecting candidates with positive cultures and dynamic teams. We even go the extra mile with our signature Consultant Appreciation Program (CAP) to help them in their future job searches. Hired by Matrix has provided talent solutions to enhance organizations’ team capacities for over three decades. As a full-service search firm, we partner with companies across industries, including Financial Services, Fintech, Consumer Goods and Services, Security and Logistics, Pharmaceutical / Biotech, Technology, Automotive, Engineering, and Healthcare. At-a-Glance: Are you ready to build your career by joining a multi-national industrial manufacturing company? If so, our client is hiring a Senior Biostatistician What You’ll Do: Senior Biostatistician will be responsible for providing technical expertise in biostatistics and to lead statistical evaluations of development and clinical validation studies. The role will interact cross-functionally with members of Clinical Affairs, Data Management, Medical Affairs, Regulatory Affairs and Global Assay Development to ensure high quality of data and analysis results used in regulatory submissions. leverage knowledge and experience in the areas of statistical techniques and programming to support product development goals within the Laboratory Diagnostics Responsible for consulting on the design of clinical trials and statistical analysis methodology for studies directed towards the development, verification, validation, and monitoring. Perform detailed review of clinical study protocols and development plans to ensure that the appropriate sample size and statistical methods are specified to support study endpoints. Authors statistical sections of protocols for development-phase projects Ensure that clinical monitoring plans, data management plans, and statistical analysis plans are harmonized and ensure delivery of high quality data and analysis results for regulatory submissions Develops statistical analysis programs to merge complex data structures from multiple databases, create analysis data set (ADS) and generate tables, listings, and figures (TLF) for reports. Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations. Ensures data specifications align with statistical analysis requirements and goals. Provides complex specifications and directions to clinical data analysts for creation of ADS and/or TLFs. What You Bring: Masters in statistic, biostatistics, or another quantitative field. Minimum 6 years of experience in biostatistics supporting development of medical diagnostics devices. Assay Migration Experience strongly desired. Responsible for providing technical expertise in biostatistics and to lead statistical evaluations of development and clinical validation studies. Expertise in Performing detailed review of clinical study protocols and development plans to ensure that the appropriate sample size and statistical methods are specified to support study endpoints. Authors statistical sections of protocols for development-phase projects Ensuring that clinical monitoring plans, data management plans, and statistical analysis plans are harmonized and ensure delivery of high-quality data and analysis results for regulatory submissions. Proficiency in statistical programming (SAS, R) and query of relational database systems (SQL). Certifications in SAS programming a plus. Experience with extraction of data and reporting within Clinical Data Management systems (e.g., Medidata RAVE, Medrio, Oracle Clinical). Experience with Open Clinica preferred. Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, survival analysis, and associated sample size calculations. Knowledge of diagnostic clinical trial statistics is required with ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems. Familiar with FDA guidelines and CLSI guidelines applicable to medical diagnostics is a plus. Experience with analysis of complex data from multiple sources. Position Type: Contract Get in Touch : We want to hear from you If you think you’d be a good match, submit your resume and reach out to Ashlesha at 332-233-8122 to learn more. Who We Are: Since 1986, Hired by Matrix, Inc. has improved our candidates’ lives with exciting job opportunities that provide outstanding career advancement. Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days, and a 401k option with a company match after one year. Hired by Matrix is an Equal Opportunity Employer and proud to be certified as both a Woman-Owned Business Enterprise and a Woman-Owned Small Business. Connect with us on LinkedIn today and learn more about how HbM can change your career: https://www.linkedin.com/company/hired-by-matrix-inc/ Check out our Career Center: https://www.hiredbymatrix.com/find-work/open-positions/