Executive Director, Statistical Programming

Executive Director, Statistical Programming Manhattan, NY Job Details Full-time $285,000

• $300,000 a year 19 hours ago Benefits Health insurance Dental insurance Vision insurance 401(k) matching Qualifications Bioinformatics FDA submissions Regulatory inspections Statistics Doctoral degree in statistics Data Integration (Data management) Azure Statistics Computer Science Automation GxP Biostatistics SAS Spark R 11+ years Google Cloud Platform Scalable systems Infrastructure architecture SAS language SQL Data quality management Team development AWS Analysis skills ICH guidelines Spark implementation Clinical research compliance Presentation skills Ph.

D. in statistics Doctor of Philosophy Team management Master of Science Quality control CDISC standards Mentoring Master's degree in statistics Scalability Regulatory submissions Master's degree in computer science Master's degree in bioinformatics Data validation Root cause analysis Senior level Regulatory audits Cross-functional collaboration Project leadership Leadership Communication skills Technical Proficiency Project stakeholder communication Python Bioinformatics Regulatory compliance management Stakeholder relationship building Cross-functional communication Statistical analysis tools Senior leadership Stakeholder management Database software proficiency Full Job Description Who we are… 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. What you'll be doing 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. You will be respo nsible for… 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. What Knowledge & Experience you'll bring to us... Education PhD or MS in Biostatistics, Statistics, Computer Science, Bioinformatics, or related quantitative field . Experience 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. Technical Expertise 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. Leadership Skills 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. Preferred Qualifications 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 . Behavioral skills to be successful... 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. What we have for you! Competitive Base Salary, Bonus, and Equity Plans Unlimited Vacation and 10 Sick Days Annually Excellent Medical, Dental, and Vision Coverage 401K with Company Matching and much more! The base pay offered will take into account internal equity and also may vary depending on the candidate's job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered. Disclaimer Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law. This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management's right to assign or reassign duties and responsibilities to this job at any time. Note to all external Recruiters & Staffing Agencies All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.