Principal Biostatistician – FTE or Contract

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

📋 Description

• Provide statistical consulting for clinical trial activities while fulfilling the responsibilities of a study statistician.

• Mentor and oversee the quality control of outputs from statistical programmers, as well as define specifications for analysis data.

• Engage with clients and clinical teams, including programmers, clinical data managers, and clinical protocol managers.

• Develop, review, and finalize statistical analysis plans.

• Validate programming deliverables and address any statistical reporting and analysis issues that arise.

• Create randomization schedules, specifications, and guidelines for usage.

• Contribute to study-specific data quality control plans and take part in data analysis and reporting.

• Develop, validate, and finalize tables and table shells for clinical study reports and other study deliverables.

• Ensure that comments from the clinical team regarding statistical reports are adequately addressed.

• Analyze data to support trial progression decisions, including conducting blinded data reviews and interim analyses.

• Collaborate on regulatory reviews, exploratory analyses, and ad-hoc analysis tasks.

• Develop SAS programs for analysis datasets and clinical trial reporting, including tables, listings, graphs, queries, and patient profile reports.

• Ensure adherence to company and industry quality standards, guidelines, and procedures.

• Perform additional duties as assigned.

⛳️ Requirements

• A Master’s degree in Statistics or Biostatistics is preferred.

• SAS® certification is preferred.

• Over 10 years of experience in the pharmaceutical or biotechnology industries, or in an equivalent statistical consulting and SAS programming role, is preferred.

• Strong experience in clinical study design, analysis, and sample size determination.

• Experience in developing randomization schedules, IVRS specifications, and usage guidelines.

• Excellent command of English with clear, concise, and accurate written and verbal communication skills.

• Ability to multitask, with strong skills in prioritization, planning, and organization.

• Proven ability to delegate tasks and lead projects effectively.

• Experience managing multiple clinical protocols simultaneously.

• Capacity to balance conflicting priorities.

• In-depth knowledge of ICH, GCP, and 21 CFR Part 11 guidelines, including FDA and EMEA requirements.

• Experience in developing statistical analysis reports and conducting statistical analyses for blinded data reviews and interim analyses.

• Familiarity with coding dictionaries such as WHO, COSTART, ICD-9, and MedDRA.

• Knowledge of CDISC data models, including SDTM and ADaM.

• Ability to develop ADaM models for clinical trial analysis and reporting.

• Comprehensive understanding of SDTM data structures.

🏝️ Benefits

• Remote work options.

• Emphasis on work-life balance.

• An inclusive culture.

• Opportunities for professional development and career advancement.

• Commitment to equal opportunity employment.

• A workplace that prioritizes diversity.