Executive Director, Statistical Programming

Nuvation Bio•Remote - Any State US, NY

About The Position

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer. The Head of Statistical Programming & Data Engineering is a senior leadership role responsible for building and leading the statistical programming and clinical data engineering functions that support clinical development, regulatory submissions, and advanced analytics. This role oversees the development of scalable data pipelines, standards-compliant clinical datasets, and statistical programming deliverables that enable high-quality decision making across clinical programs. The position partners closely with Biostatistics, Clinical Data Management, Clinical Operations, Regulatory Affairs, and external vendors to ensure timely and compliant delivery of analysis datasets, tables/listings/figures (TLFs), and regulatory submission packages.The successful candidate will combine deep expertise in clinical statistical programming with modern data engineering practices, helping transform clinical data workflows through automation, reproducibility, and scalable infrastructure.

Requirements

PhD or MS in Biostatistics, Statistics, Computer Science, Bioinformatics, or related quantitative field .
15+ years of experience in statistical programming within biotech, pharma, or CRO environments .
5+ years leading statistical programming teams.
Demonstrated experience supporting regulatory submissions (NDA/BLA/MAA) .
A combination of education and experience may be considered for this role.
Advanced proficiency in SAS, R, SQL
Strong experience with CDISC standards (SDTM, ADaM) .
Experience implementing modern data engineering tools (Python, Spark, cloud platforms, workflow orchestration tools).
Experience building automated and reproducible analysis pipelines.
Proven ability to build and scale high-performing technical teams.
Strong project management and cross-functional leadership capabilities.
Excellent communication skills with both technical and non-technical stakeholders.
Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
Emotional intelligence , curiosity, and a knack to figure out a way to build something better
Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.

Nice To Haves

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

Responsibilities

Leadership & Strategy Build, lead, and mentor a high-performing team of statistical programmers and data engineers.
Define the strategy and roadmap for statistical programming and clinical data engineering capabilities.
Establish scalable, reproducible data and analysis workflows supporting clinical development and regulatory submissions.
Develop departmental standards, best practices, and governance for programming and data engineering.
Statistical Programming Oversee the creation and validation of regulatory-compliant datasets including SDTM, ADaM, and analysis datasets .
Ensure timely production and quality control of Tables, Listings, and Figures (TLFs) for clinical study reports and submissions.
Support regulatory filings including IND, NDA, BLA, and global submissions .
Ensure compliance with regulatory guidance and industry standards such as CDISC , FDA , and ICH .
Data Engineering & Infrastructure Design and maintain scalable data pipelines for clinical data integration.
Implement modern data platforms enabling automated ingestion, transformation, and quality monitoring.
Collaborate with IT, QA, and data science teams to enable analytics-ready clinical data environments.
Implement reproducible analysis pipelines and workflow automation.
Cross-Functional Collaboration Partner with Biostatistics to implement statistical analysis plans.
Work closely with Clinical Data Management to ensure data quality and standards alignment.
Coordinate with external CROs and vendors to ensure consistent programming standards and deliverables.
Quality & Compliance Ensure all programming activities meet GxP , 21 CFR Part 11 , and regulatory expectations.
Establish rigorous quality control processes for datasets and statistical outputs.
Support regulatory inspections and audits.