Senior Biostatistician

Senior Biostatisticians – Bridgewater, New Jersey, USA (On‑site or Remote)

We are seeking committed, skilled, and customer‑focused individuals to join our winning team as senior biostatisticians.

• 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.
• Project Leadership:
  Lead assigned projects by applying project management skills, statistical and programming techniques; achieve quality and on‑time delivery of deliverables, earn client’s trust and repeat business.
• Statistical Planning and Methodologies:
  Provide statistical expertise for design, analysis and reporting of clinical trials and research projects.
• Protocol Development:
  Contribute to the writing of statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes.
• Statistical Analysis Plans:
  Write Statistical Analysis Plans (SAPs) and properly address peer statistician review comments.
• Quality Assurance:
  Create and maintain Statistical and Programming Quality Control (QC) and QA Plans for assigned projects.
• Data Management Input:
  Provide input to unblinded data management plan when required.
• Methodology Development:
  Assist in research and development of statistical methodologies and processes.
• Statistical Programming:
  Develop and/or review ADaM dataset specifications; review and provide input to SDTM dataset specifications when required.
• Dataset Validation:
  Perform QC validation of analysis datasets and TLGs.
• Run Reviews:
  Perform third‑level review of dry runs and final runs.
• Dry‑Run Leadership:
  Lead statistical dry runs and final runs 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.
• Document Review:
  Review and provide input to the Analysis Data Reviewer’s Guide; discuss and incorporate Data Standards Reviewer’s review comments to ensure quality of the document.
• Statistical Analysis and Reporting:
  Perform statistical analysis as per SAP, and address peer/QC review comments and findings.
• Core Results Validation:
  Perform statistical validation of core results, address additional QC validation comments and findings on the core results.
• Reporting Meetings:
  Plan and conduct or contribute to the trial results reporting/dissemination meetings.
• Clinical Study Report:
  Under supervision 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.
• Statistical Reporting:
  Write statistical report or statistical sections of the CSR.
• Publication Support:
  Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters.
• 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.
• Data Management Plan Review:
  Review Data Management Plan sections relating to critical data collection and cleaning; provide statistical input to Data Validation Specification.
• Database Quality Checks:
  Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution.
• Data Quality Communication:
  Perform ongoing assessment and communication of data quality issues, including protocol deviations.
• Database Lock:
  Assist data management and trial management team in preparing for database lock.
• Compliance and Training:
  Complete job‑required and project‑specific training; comply with applicable Everest and trial sponsor’s policies, SOPs, and work instructions.
• File Archiving:
  Properly archive study files in accordance with trial sponsor’s requirements.
• Professional Development:
  Plan and carry out professional development…