Principal Biostatistician

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

📋 Description

• Oversee clinical trial programs and projects for one or more clients while managing Statistical Operations.

• Provide daily technical and operational guidance to project teams.

• Ensure statistical oversight for designated drug development programs and projects.

• Contribute statistical insights during protocol design and development.

• Engage in the writing of trial protocols and research proposals.

• Act as the lead biostatistician for interdisciplinary teams, making strategic contributions to drug development and commercialization.

• Review deliverables related to clinical data management, including eCRFs, completion instructions, validation specifications, data review plans, and data management plans.

• Draft Statistical Analysis Plans, Statistical Reports, and the statistical methodology sections of Clinical Study Reports.

• Conduct peer reviews of SAPs and other technical documentation.

• Execute hands-on statistical analysis and modeling tasks.

• Validate statistical tables, listings, and figures.

• Perform quality control reviews on statistical deliverables.

• Review and validate ADaM dataset specifications while ensuring quality control on ADaM datasets.

• Consult with medical and clinical trial personnel regarding the publication of trial outcomes.

• Take part in authoring abstracts, manuscripts, posters, and presentations.

• Ensure compliance of statistical and programming activities with regulatory requirements and standards.

• Interact with regulatory bodies and assist sponsors in new drug application processes.

• Manage statistical and programming resources, including capacity analysis, benchmarking, and metrics.

• Maintain and enhance governing documents related to statistical and programming practices.

• Participate in the interviewing and assessment of professional candidates.

⛳️ Requirements

• A Ph.D. in statistical science, mathematical analysis, or related fields with a minimum of 7 years of relevant experience, or a Master’s degree in these areas with at least 10 years of relevant experience.

• Proven track record of exceptional ability and performance.

• Proficiency in statistical methodologies pertaining to study design, sample size estimation, statistical analysis planning, modeling, data handling, analysis, and reporting.

• Experience with clinical trial programs and drug development processes.

• Thorough understanding of regulatory requirements and applicable standards/conventions.

• Familiarity with ADaM datasets and specifications.

• Knowledge of CDISC and the requirements/expectations of regulatory agencies.

• Capability to perform statistical analysis, modeling, validation, and quality control activities.

• Ability to coach, mentor, and technically review Biostatisticians and Statistical Programmers.

• Skill in interacting with regulatory bodies and supporting new drug applications.

• Competence in participating in interviews and evaluating professional candidates.

🏝️ Benefits

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Life & AD&D insurance.

• Short- and long-term disability coverage.

• Tuition reimbursement program.

• Fitness reimbursement.

• Employee assistance program (EAP).

• 401(k) retirement/pension plan.

• Generous paid time off and sick leave.

• Opportunity to earn a performance-based bonus.

• Work from home policy.