Biostatistician – Clinical Trials (Drug/Biologic)

Job Summary of the Biostatistician

The Biostatistician is responsible for the design and conduct of clinical research studies including developing statistical analysis plans, performing basic and complex statistical analysis, interpretation and reporting of study results and other required activities as needed. Responsibilities include providing data analysis input to meet project objectives, contributing to statistical analysis sections of IRB and grant applications, developing and executing statistical programs to perform analyses and prepare data displays, drafting analysis and results sections for clinical study reports and scientific papers, and supporting general publication of study findings.    

Requirements of the Biostatistician

• A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 3 years’ relevant experience or a master’s degree plus 6 years’ relevant experience with demonstrated ability and sustained performance at the Ph.D. level.
• 5+ years of experience working in the biologic/biotechnology, pharmaceutical, and/or medical device industry
• Demonstrated success in delivering on goals and being part of fast-moving, collaborative team
• Broad regulatory understanding of functions and processes involved in pharmaceutical, biologic, and/or medical device product development
• Must demonstrate strong interpersonal, written, and oral communication skills across various levels of management and demonstrate the ability to manage differences and needs between multiple stakeholders

Responsibilities of the Biostatistician

The specific duties of the Biostatistician include but are not limited to:

• Leadership and Project Management:
  • Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations.
  • Apply project management skills, statistical and programming techniques, and achieve quality and on time delivery of deliverables.
  • Coordinate activities with project/program overall management personnel to achieve program objectives.
  • Under supervision may represent the company to interact with regulatory agencies regarding matters relating to the statistical areas of the responsible projects/programs.
• Statistical Planning and Methodologies:
  • Provide strong statistical expertise for design, analysis and reporting of clinical trials and research projects.
  • Write statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes.
  • Write Statistical Analysis Plans (SAPs) and properly address quality control (QC) review comments.
  • Create and maintain Statistical and Programming QC and QA Plans for assigned projects or programs.
  • Provide input to unblinded data management plan when required.
  • Participate or lead research and development of statistical methodologies and processes.
  • Lead efforts in planning, researching and designing statistical methods and approaches in solving complex trial data analysis and operational issues.
• Statistical Programming:
  • Develop and/or review ADaM and/or SDTM dataset specifications. Lead efforts in resolving complex data derivation and data handling issues.
  • Perform statistical programming to either build analysis datasets and generate statistical tables, listings and graphs (TLGs) or perform QC validation of these datasets and TLGs.
  • Lead statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues.
  • Review and provide input to Data Standards
  • Review comments to ensure quality of documents.
  • Perform QC programmatic checks on core study results as well as overall quality/consistency review of statistical TLGs.
• Statistical Analysis and Reporting, Publication Support:
  • Perform complex statistical modeling and analyses, implement new statistical analysis methods and strategies.
  • Perform statistical analysis as per SAP, and address peer/QC review comments and findings.
  • Perform statistical validation of core results, address additional QC validation comments and findings on the core results.
  • Plan and conduct or contribute to the trial results reporting.
  • Contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results.
  • Write statistical report or statistical sections of the CSR, or perform peer review of the contents.
  • Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters.
• Supporting Clinical Data Collection and Cleaning:
  • Provide statistical input to Case Report Forms (CRF) design and database/variable structure.
  • Provide statistical input to non-CRF data collection and acquisition methods and approaches.
  • Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification.
  • Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution.
  • Perform ongoing assessment and communication of data quality issues, including protocol deviations.
  • Assist data management and trial management team in preparing for database lock.
• Perform other duties as directed by the Supervisor

Location

Remote

OR

111 West Oak Ave., Tampa, FL  33602

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Benefits/Compensation