Biostatistician II

Name of Employer: Everest Clinical Research Corporation

Job Location: 100 Somerset Corporate Boulevard, Suite 3001, Bridgewater, NJ 08807

Job Title: Biostatistician II

Job Duties: Leadership and Project Management: Lead efforts in resolving day-to-day work-related issues and problems, securing quality, and improving efficiency and productivity of statistical and programming operations. Lead assigned projects by applying project management skills, and 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. With supervision, contribute to the writing of 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. Provide input to unblinded Data Management Plan when required. 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. 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 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, Publication Support: Perform statistical analysis per the 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/dissemination meetings. 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 the CSR to ensure accuracy, completeness, and appropriateness of the interpretation of the statistical results. Write the statistical report or statistical sections of the CSR. 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. Complete job required and project-specific training. Comply with applicable Everest and trial Sponsor’s Policies, SOPs, and Work Instructions. Properly archive study files in accordance with trial sponsor’s requirements. Plan and carry out professional development activities. WFH is an option. Multiple openings.

Job Requirements: Master’s degree in Statistical Science, Biostatistics or Mathematical Analysis. 48 months of experience in any statistical occupation. Experience must include 48 months of experience in statistical consulting, programming, and/or data management. WFH is an option. Multiple openings.

Rate of Pay: $115,000.00 per year

TO APPLY, please visit https://www.jobpostingtoday.com/application/32304/apply and see Job ID: 32304.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)