Executive Director, Statistical Programming (Biotech)

TL;DR

Executive Director, Statistical Programming (Biotech): Building and leading statistical programming and clinical data engineering functions supporting clinical development, regulatory submissions, and advanced analytics with an accent on scalable data pipelines, standards-compliant datasets, and TLFs. Focus on implementing automation, reproducibility, CDISC standards, and cross-functional collaboration for high-quality decision-making.

Location: Remote - Any State US

Salary: From $285,000 to $300,000 per year

Company

Biopharmaceutical company developing novel therapeutic candidates to address unmet needs in oncology.

What you will do

• Build, lead, and mentor a team of statistical programmers and data engineers.
• Define strategy and roadmap for statistical programming and clinical data engineering.
• Oversee creation and validation of regulatory-compliant datasets (SDTM, ADaM) and TLFs.
• Design scalable data pipelines and implement modern data platforms for clinical data integration.
• Partner with Biostatistics, Clinical Data Management, and external vendors for compliant deliverables.
• Ensure compliance with GxP, 21 CFR Part 11, CDISC, FDA, and ICH standards.

Requirements

• PhD or MS in Biostatistics, Statistics, Computer Science, Bioinformatics, or related field.
• 15+ years in statistical programming in biotech, pharma, or CRO; 5+ years leading teams.
• Experience supporting regulatory submissions (IND, NDA, BLA).
• Advanced proficiency in SAS, R, SQL; strong CDISC (SDTM, ADaM) experience.
• Experience with modern data engineering tools (Python, Spark, cloud platforms).
• Proven leadership in building technical teams and cross-functional collaboration.

Nice to have

• Experience in early-stage biotech.
• Cloud-based data platforms (AWS, GCP, Azure).
• Knowledge of real-world data, biomarker, or multi-omics datasets.

Culture & Benefits

• Competitive base salary, bonus, and equity.
• Unlimited vacation and 10 sick days annually.
• Excellent medical, dental, vision coverage.
• 401K with company matching.