The Director of Biostatistics will provide leadership and oversight for biostatistical activities supporting National Institutes of Health (NIH)-funded clinical research programs. Reporting to the Chief Science Officer, this position is responsible for the design, analysis, interpretation, and reporting of clinical research data across multiple studies. The Director of Biostatistics will lead statistical strategy, supervise statistical personnel, and collaborate with investigators, sponsors, Data and Safety Monitoring Boards (DSMBs), and federal stakeholders to ensure scientifically rigorous and regulatory-compliant research outcomes.

Essential Duties and Responsibilities

• Lead and oversee biostatistical activities across the lifecycle of clinical research studies.
• Supervise and mentor statisticians and statistical programmers.
• Develop and review Statistical Analysis Plans (SAPs), power analyses, sample size determinations, and adaptive randomization strategies.
• Provide statistical leadership for study design, protocol development, and endpoint evaluation.
• Oversee SAS programming and statistical analyses conducted on clean, locked datasets.
• Prepare and review statistical reports, tables, listings, figures, and other study deliverables.
• Support DSMB activities through preparation of interim analyses evaluating treatment effectiveness, safety, and study outcomes.
• Conduct and oversee additional analyses requested by DSMBs, study investigators, sponsors, or Contracting Officer Representatives (CORs).
• Develop study-specific statistical methodologies when standard approaches do not adequately address research objectives.
• Support preparation of Final Clinical Study Reports in accordance with ICH E3 guidance and approved Statistical Analysis Plans.
• Collaborate with investigators and research teams to prepare analyses, publications, presentations, and scientific manuscripts.
• Create publication-ready tables, figures, datasets, and supporting statistical documentation.
• Ensure compliance with applicable regulatory requirements, Good Clinical Practice (GCP), sponsor expectations, and organizational quality standards.
• Manage project timelines, priorities, and statistical deliverables across multiple studies.

Required Qualifications

• PhD preferred in Statistics, Biostatistics, Bioinformatics, or a related quantitative discipline.
• Minimum of 10 years of experience in the pharmaceutical, biotechnology, clinical research, or contract research organization (CRO) industry.
• Demonstrated experience leading biostatistical activities for clinical trials and complex research studies.
• Extensive experience with:

1. Statistical Analysis Plan development
2. Power analysis and sample size determination
3. Adaptive trial designs and randomization methodologies
4. SAS programming
5. Clinical trial data analysis
6. Statistical reporting and regulatory submissions

• Strong understanding of advanced statistical methods and clinical research methodology.
• Experience supporting DSMBs and preparing statistical analyses for regulatory review.
• Proven ability to lead and mentor statistical teams.

Preferred Qualifications

• Experience supporting National Institutes of Health (NIH)-funded research.
• Experience working within federal contracting environments.
• Familiarity with federal acquisition processes and government-funded research programs.
• Experience supporting submissions to regulatory agencies, including the U.S. Food and Drug Administration (FDA).

Knowledge, Skills, and Abilities

• Advanced expertise in biostatistics and clinical trial methodology.
• Strong project management and organizational skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Exceptional written and verbal communication skills.
• Ability to collaborate effectively with multidisciplinary teams and federal stakeholders.
• Demonstrated commitment to scientific integrity, quality, and regulatory compliance.

Travel Requirements:

• Occasional travel to client sites, research facilities, or industry events may be required.

Work Environment:

• Remote-first, with flexibility to adapt to evolving program needs and organizational priorities.

Physical Demands:

• Ability to participate in virtual meetings, presentations, and program activities for extended periods.

Equal Employment Opportunity

Phronetik is an equal opportunity employer and is committed to creating a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to any protected status under applicable law.

Contingency Statement

This position is contingent upon contract award, funding availability, and satisfaction of all applicable employment requirements.