Director, Statistical Programming

Posted 2 days agoViewed

💎 Seniority level: Director, 8-10+ years

💸 Salary: 220000.0 - 239000.0 USD per year

🔍 Industry: Biotechnology

🏢 Company: Spyre Therapeutics👥 1-50💰 $180,000,000 Post-IPO Equity over 1 year agoBiotechnology Therapeutics

⏳ Experience: 8-10+ years

Requirements:

MS Degree in Biostatistics, Statistics, or a related field with 8-10+ years of experience in statistical programming within the pharmaceutical, biotech, or CRO industry.

Extensive experience in the life sciences sector with a strong understanding of drug development processes.

Extensive experience with CDISC standards (SDTM, ADaM, define.xml) and their application in clinical studies across all phases.

Strong proficiency in SAS programming, including macro development, ODS graphics, and experience with SAS/STAT procedures

Thorough understanding of regulatory requirements for statistical programming in submissions to FDA, EMA, PMDA, and other health authorities.

Experience in preparing and reviewing key documents for regulatory submissions (e.g., SAP, SDTM/ADaM spec, Define files, Reviewer's Guide).

Proficiency in electronic data capture (EDC) systems and clinical data management processes, relational database structures, and data workflow.

Experience with data visualization tools (e.g., R Shiny, Spotfire, Tableau) is a plus.

Familiarity with cloud-based computing environments and big data technologies.

Excellent project management skills and ability to handle multiple projects simultaneously.

Successful track record of working independently in a matrixed organization and providing solutions to emerging problems.

Excellent interpersonal communication skills, along with organizational skills.

Excellent communication and interpersonal skills.

Ability to work collaboratively in a multidisciplinary team environment.

Responsibilities:

Develop and implement statistical programming strategies and best practices for clinical trials across all phases, ensuring alignment with company goals, industry standards, and regulatory requirements.

Oversee the creation and validation of CDISC-compliant SDTM and ADaM datasets, with a focus on study-specific data structures and endpoints.

Direct the development of tables, listings, and figures (TLFs) for clinical study reports, regulatory submissions (e.g., DSUR), and publications.

Ensure compliance with FDA, EMA, PMDA and other regulatory agency requirements for statistical programming deliverables in submissions.

Assist managing resource allocation, project timelines, and deliverables for multiple studies simultaneously, including outsourced work to CROs.

Serve as the statistical programming representative in cross-functional study teams and external collaborations.

Contribute to the development and improvement of department SOPs, working instructions, and quality control processes.

Stay current with evolving trends in I&I clinical trials, statistical methodologies, and programming techniques, and implement innovative approaches as appropriate.

Contribute to regulatory interactions and represent statistical programming in regulatory meetings when needed.

All other duties as assigned.

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