Senior Biostatistician

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer statistical support for clinical trials from the initiation phase through to final reporting and regulatory submission.

• Provide statistical insights for study design, including sample size assessment, endpoint definition, randomization, and analysis strategy.

• Author or review the statistical sections of protocols, statistical analysis plans, mock shells, and various study documents.

• Collaborate with sponsors, clinical teams, data managers, statistical programmers, medical writers, and regulatory teams throughout the entire study lifecycle.

• Examine statistical analyses and outputs, such as tables, listings, and figures, to ensure quality, accuracy, and consistency.

• Assist with interim analyses, safety reviews, efficacy analyses, and the final study reporting.

• Engage in the review of ADaM specifications, derived endpoints, and analysis datasets.

• Aid in the preparation of DMC materials, including reviewing analysis outputs and summaries for DMC meetings, following applicable procedures and confidentiality requirements.

• Interpret statistical results and convey findings clearly to internal teams and sponsors.

• Ensure timely completion of study deliverables in compliance with SOPs, regulatory standards, and sponsor expectations.

• Assist with responses to sponsor inquiries, audit requests, and questions from health authorities concerning statistical issues.

• Provide mentorship to junior statisticians and contribute to departmental process improvement and standardization initiatives.

• Participate in proposal development, bid defenses, and budget assumptions as necessary.

• Support oncology studies with endpoints such as ORR, DOR, PFS, OS, BOR, CBR, and TTR.

• Contribute to statistical strategies for time-to-event analyses, censoring rules, subgroup analyses, and sensitivity analyses.

• Support studies utilizing RECIST, iRECIST, or other disease-specific response criteria, as applicable.

• Assist in statistical activities related to DMC/IDMC reviews for ongoing clinical trials.

• Help prepare and review DMC analysis outputs, safety summaries, and meeting materials.

• Contribute to the review of DMC charters and statistical content, where applicable.

• Work efficiently within blinded and unblinded team structures while maintaining strict confidentiality.

⛳️ Requirements

• Master’s degree or PhD in Statistics, Biostatistics, or a related quantitative discipline.

• Generally, 5 to 8+ years of pertinent biostatistics experience in clinical research, pharmaceutical, biotechnology, or CRO environments.

• Experience in a CRO setting is strongly preferred.

• Preferred experience with oncology clinical trials.

• Prior involvement in DMC/IDMC activities is preferred.

• In-depth knowledge of statistical methodologies employed in clinical trials, including survival analysis, categorical data analysis, and longitudinal data analysis.

• Solid understanding of ICH, GCP, and relevant regulatory requirements.

• Experience in developing or reviewing SAPs, protocols, and statistical outputs.

• Familiarity with CDISC standards, including SDTM and ADaM.

• Proficiency in SAS is required; familiarity with R is advantageous.

• Excellent written and verbal communication skills.

• Ability to manage multiple studies and priorities within a fast-paced CRO environment.

🏝️ Benefits

• Selection of comprehensive Medical, Vision, and Dental Insurance plans.

• Paid vacation and sick leave.

• Annual corporate holidays.

• Participation in the 401K Plan.

• Extensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.

• Access to Health Advocate and Employee Assistance Program.