Principal Statistician

Company: RCM Technologies
Location: Danvers
Posted on: September 25, 2022

Job Description:

RCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.Principal StatisticianReporting to the Director of Statistics, the Principal Statistician will provide statistical expertise in the design, analysis, and interpretation of clinical trial programs, regulatory submission and filings; and the generation of evidence to support publication and product commercialization. The Principal Statistician will play a leadership role in multi-disciplinary project and study teams and will also interact closely with various steering committees for our client sponsored prospective randomized studies and registries.Responsibilities for Principal Statistician: Contribute to the strategic and statistical thinking in relevant product and study teams Develop trial design options and provide guidance and leadership for on-going and planned clinical studies Participate in planning, design, development, and execution of clinical trial protocols Develop statistical sections of clinical study documents, including but not limited to clinical study report, statistical analysis plan (SAP), and study synopsis/protocol Evaluate data quality, perform statistical edit checks of source data Produce and validate statistical analyses and outputs according to SAP Lead and support data analyses to enable generation of clinical evidence manuscripts Perform quality control and validation of peer statistician's work Provide validation and review services for internal and external projects. Write up and communicate findings as necessary Maintain archives of study data and relevant programming documentation Lead and assist the development of internal guidelines and Standard Operating Procedures Conduct statistical simulations for evaluating and developing Client clinical trial designs Prepare project updates for weekly/monthly status meetings Maintain up to date knowledge of statistical methodology and relevant regulatory guidanceQualifications: PhD or MS in Statistics, Biostatistics, Mathematics or similar area Minimum of seven years of clinical research experience in medical device, pharmaceutical, biotech and/or CRO industries Extensive experience in clinical trial design, data analysis and interpretation, as well as regulatory interaction and/or submission Proficient in major statistical programming languages such as SAS and R Adequate knowledge in Database Management Ability to work collaboratively with others in a team environment Possess excellent interpersonal skill Strong oral and written communication skillRCM Technologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCM encourages applicants of all ages.

Keywords: RCM Technologies, Boston , Principal Statistician, Other , Danvers, Massachusetts