Director of Biostatistics

No 3rd party candidates

Contract-to-Hire

On-Site - Candidates must be local to Gaithersburg, MD

Job Summary:

Reporting to the Vice President of Biostatistics and Data Management, this individual will provide statistical leadership and serve as a study statistician within development. S/he will work collaboratively with clinical and development teams, including clinicians, clinical scientists, statistical programmers, data managers, regulatory, and clinical operations professionals, to plan, conduct, and analyze clinical studies of all phases. Responsible for the overall quality of statistical design, programming, analysis, and data reporting. Represents the company in interactions with outside statistical and data management service providers and participates in discussions with regulatory agencies.

Essential Functions:

• Provides statistical expertise and leadership to ensure program objectives are in alignment with regulatory and clinical study designs
• Working closely with statistical programmers to provide outputs and analyses to support NDA/BLA submission to regulatory authorities
• Contribute to strategic planning and go/no go decision guidance
• Directs development of statistical analysis plans and reviews statistical programming
• Ensures timely and accurate delivery of clinical study data analysis results
• Interprets clinical trial data and contributes to the preparation of clinical manuscripts and regulatory submission documents
• Lead statistical strategy for clinical development programs, including MASH and obesity indications.
• Develop and review statistical sections of protocols, SAPs, CRFs, and clinical study reports.
• Collaborate with cross-functional teams (Clinical, Regulatory, Data Management, Medical Affairs) to ensure alignment on study design and analysis.
• Oversee statistical deliverables from CROs and ensure quality and compliance with ICH-GCP and regulatory standards.
• Perform or supervise statistical analyses for interim and final study results.
• Contribute to regulatory submissions (INDs, NDAs, BLAs) and responses to health authorities.
• Support external publications and presentations of clinical data.
• Mentor statistical programmer in AI/ML area and contribute to departmental growth and innovation.
• Evaluate and implement innovative statistical techniques that will provide benefit to clinical development programs

Job Requirements (Essential knowledge, skills, and attributes):

• PhD or Master’s in Statistics, Biostatistics, or related field. MS with significant industry experience
• At least 5 years of prior experience working for biotech, pharma, or CRO
• 5 years (Associate Director) / 8 years (Director) of experience in clinical trial statistics within biotech/pharma.
• Strong knowledge of statistical methods for clinical trials, including longitudinal data, survival analysis, and Bayesian approaches.
• Experience with regulatory interactions and submissions.
• Experience with metabolic diseases is highly desirable
• Proficiency in SAS and/or R; experience with CDISC standards (SDTM, ADaM).
• Excellent communication and leadership skills
• A self-directed individual who can excel both independently and as a team player in a fast-paced, entrepreneurial environment
• History of successful participation within an interdisciplinary team.

Preferred Experience

• Prior work in liver disease or metabolic indications (e.g., NASH/MASH, obesity)
• Experience with external control arms or synthetic cohort matching
• Familiarity with non-invasive biomarkers and imaging endpoints
• Working experience or knowledge with AI/ML.