Senior Biostatistician

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Oversee the resolution of daily work-related challenges and enhance the quality, efficiency, and productivity of statistical and programming operations.

• Manage designated clinical research projects utilizing project management, statistical, and programming methodologies.

• Ensure timely delivery of high-quality project outputs while fostering client trust and encouraging repeat business.

• Offer statistical expertise for the design, analysis, and reporting of clinical trials and research projects.

• Draft the statistical sections of study protocols and Statistical Analysis Plans (SAPs).

• Create and review ADaM dataset specifications and evaluate SDTM specifications.

• Conduct QC validation of analysis datasets, tables, listings, and graphs (TLGs).

• Direct statistical dry runs and final executions, manage resources, address programming and data challenges, and collaborate with data management.

• Review Analysis Data Reviewer’s Guides and integrate comments from standards reviews.

• Execute statistical analyses and validation, respond to peer/QC review findings, and assist in results dissemination meetings.

• Contribute to and review Clinical Study Reports (CSRs).

• Conduct statistical analyses for abstracts, manuscripts, presentations, and posters.

• Assist in the design of CRFs, database structures, non-CRF data collection, validation specifications, and preparation for database lock.

• Fulfill necessary training, adhere to policies and SOPs, archive study files, and engage in professional development activities.

⛳️ Requirements

• A Ph.D. in statistical science, mathematical analysis, or a related field with 2 years of relevant experience, or a Master’s degree with 4 years of pertinent experience.

• Proven capability and consistent performance.

• Statistical proficiency in the design, analysis, and reporting of clinical trials and research projects.

• Experience with sample size calculations and randomization specifications/codes.

• Competence in writing Statistical Analysis Plans (SAPs).

• Familiarity with ADaM and SDTM dataset specifications.

• Experience in conducting QC validation of analysis datasets and TLGs.

• Background in statistical analysis, validation, and reporting for Clinical Study Reports (CSRs) and publications.

• Ability to provide statistical input for CRF design, database/variable structures, data collection, and data cleaning.

• Capacity to complete required training and adhere to Everest and sponsor policies, SOPs, and work instructions.

• Proficient in properly archiving study files.

• Dedication to professional development.

🏝️ Benefits

• Coverage for medical, dental, and vision needs.

• Life and AD&D insurance.

• Short-term and long-term disability benefits.

• Tuition reimbursement opportunities.

• Fitness reimbursement.

• Employee assistance program (EAP).

• 401(k) retirement/pension plan.

• Generous paid time off and sick leave.

• Potential to earn a performance-based bonus.

• Opportunities for professional development activities.