Senior Director of Biometrics
Scienta, Boston, MA, United States
Company: Oncology Clinical Stage Biotech
Position Type: Permanent
The Opportunity
A well-funded, clinical-stage oncology biotech is seeking a Senior Director / Executive Director of Biostatistics to serve as the functional head of Biometrics.
This role offers a rare opportunity to combine hands‑on statistical leadership with enterprise‑level strategy, owning the full biometrics vision while building a scalable function spanning Biostatistics, Statistical Programming, and Data Management over time.
You will act as a key scientific and operational leader, partnering closely with Clinical Development, Regulatory, Medical, and senior leadership to support an expanding oncology pipeline.
Key Responsibilities
- Act as the functional lead for Biometrics, with primary ownership of Biostatistics and strategic oversight of Statistical Programming and Data Management
- Define and execute biometrics strategy across all clinical development programs
- Provide hands‑on statistical leadership including study design, protocol input, SAPs, analysis, interpretation, and reporting
- Serve as the senior statistical voice in cross‑functional and executive‑level discussions
- Lead statistical contributions to regulatory interactions and submissions (FDA, EMA, etc.)
- Establish biometrics standards, processes, governance, and vendor models
- Oversee CROs and external partners across biostatistics, programming, and data
- Build and scale the internal Biometrics organisation, including hiring, mentoring, and functional integration
- Contribute to portfolio, development, and corporate strategy as a senior leader
Required Background
- PhD or MSc in Biostatistics, Statistics, or related quantitative discipline
- Significant experience in oncology clinical development within biotech or pharma
- Demonstrated leadership
- Strong hands‑on statistical expertise across multiple phases of clinical trials
- Experience influencing or overseeing wider biometrics functions (e.g., programming, data management)
- Deep understanding of regulatory expectations and submission requirements
- Comfortable operating in a build‑phase environment with high autonomy and accountability