The Director of Statistical Programming oversees statistical programming activities, ensuring timely and high-quality deliverables, while leading a team, collaborating with stakeholders, and ensuring compliance with regulatory guidelines.
The Director, Statistical Programming will support and oversee all statistical and clinical programming activities from all development programs and is responsible for planning, monitoring, organizing and reviewing activities of statistical programming team, to ensure analyses are delivered on time, on budget with rigor and quality, by working with Biostatistics, Clinical Data Management, and other functional stakeholders. The position serves as an in-house expert for statistical programing and data standards, and assists the Head of Biometrics and team to develop functional strategies and drives the development and continuous improvement of departmental procedures, training and standards.
Title: Director, Statistical Programming
Reporting to: VP, Biometrics
Location: Remote
Responsibilities
- Leadership and Management:
- Lead and manage statistical programming activities for clinical studies, ensuring high-quality deliverables and adherence to established timelines. Allocate resources effectively and promote resource sharing across programs to meet departmental and organizational goals.
- Cross-Functional Collaboration:
- Collaborate with biostatisticians, data managers, and cross-functional teams to define programming strategies and requirements, ensuring alignment with overall clinical and regulatory objectives.
- Programming and Data Development:
- Develop, validate, and maintain analysis datasets in compliance with CDISC standards, as well as tables, listings, and figures (TLFs) in accordance with regulatory guidelines and internal standards.
- Statistical Analysis Planning:
- Review Statistical Analysis Plans (SAPs) to provide feedback, technical input, and strategic recommendations for successful execution.
- Regulatory Submissions:
- Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), ensuring compliance with eCTD and electronic submission standards.
- Process Optimization:
- Build and maintain software-agnostic solutions and macros to automate repetitive tasks and improve programming efficiency.
- Team Development:
- Manage, mentor, and guide junior programmers, fostering their professional growth and ensuring consistent quality across deliverables.
- Continuous Improvement:
- Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis to enhance team capabilities and process efficiency.
Qualifications
- MS degree in Statistics, Computer Science, Mathematics, or a related field
- At least 12 years of experience in the pharmaceutical industry; direct supervisory experience and successful submission experience strongly preferred
- Thorough understanding of ICH Guidelines, relevant regulatory requirements, and CDISC standards
- Familiarity with the expectations of regulatory agencies such as the FDA and EMA
- Direct experience with NDA/BLA or other regulatory filings, including ISS or ISE
- Demonstrated experience in departmental resource allocation
- Ability to work effectively and efficiently both independently and as part of a cross-functional team
- Strong attention to detail and awareness to escalate issues appropriately
The salary range for this position is from $215,000 to 235,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan
Top Skills
Cdisc Standards
Ectd
Ema
Fda
Similar Jobs
Healthtech • Pharmaceutical • Industrial • Manufacturing
The Associate Director leads clinical studies, manages a team, implements statistical analysis plans, and creates statistical programming documents using SAS. They collaborate with cross-functional teams and generate analysis files for regulatory submissions, demonstrating coaching skills in mentoring programmers.
Top Skills:
R ShinySASSas BaseSas MacrosSas/GraphSas/OdsSas/SqlSas/StatSpotfire
Biotech • Pharmaceutical
The Associate Director leads statistical programming for regulatory submissions, manages CROs, collaborates on CRFs, and ensures compliance with CDISC standards.
Top Skills:
AdamBase SasCdiscSASSas/GraphSas/StatSdtm
.png)
Artificial Intelligence • Blockchain • Fintech • Financial Services • Cryptocurrency • NFT • Web3
Lead and manage an engineering team focused on delivering blockchain-based financial products. Drive technical excellence and foster a quality-focused environment while collaborating across the organization.
Top Skills:
BlockchainDistributed SystemsPeer To Peer PaymentsSoftware Engineering
What you need to know about the Los Angeles Tech Scene
Los Angeles is a global leader in entertainment, so it’s no surprise that many of the biggest players in streaming, digital media and game development call the city home. But the city boasts plenty of non-entertainment innovation as well, with tech companies spanning verticals like AI, fintech, e-commerce and biotech. With major universities like Caltech, UCLA, USC and the nearby UC Irvine, the city has a steady supply of top-flight tech and engineering talent — not counting the graduates flocking to Los Angeles from across the world to enjoy its beaches, culture and year-round temperate climate.
Key Facts About Los Angeles Tech
- Number of Tech Workers: 375,800; 5.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Snap, Netflix, SpaceX, Disney, Google
- Key Industries: Artificial intelligence, adtech, media, software, game development
- Funding Landscape: $11.6 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Strong Ventures, Fifth Wall, Upfront Ventures, Mucker Capital, Kittyhawk Ventures
- Research Centers and Universities: California Institute of Technology, UCLA, University of Southern California, UC Irvine, Pepperdine, California Institute for Immunology and Immunotherapy, Center for Quantum Science and Engineering
