Wave Life Sciences · 12 hours ago
Associate Director, Statistical Programming / Principal Statistical Programmer
Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. The Associate Director, Statistical Programming / Principal Statistical Programmer will lead and oversee statistical programming for clinical trials, ensuring high-quality and regulatory-compliant statistical deliverables.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Manage and oversee vendors, contractors and internal personnel to accomplish statistical programming activities for clinical trials. Provide accountability for external vendor timeline management
Author CDISC-compliant dataset specifications including definitions and documentation of endpoint algorithm programming
Develop and validate programs to analyze clinical trial data and to report results in tables, listings and figures
Manage the end-to-end programming of deliverables from CRF collection through electronic submission including preparation of electronic submissions components
Contribute to the development, implementation, and versioning of statistical programming practices and standards
Review, and comment on CRFs, annotated CRFs, and edit checks and related documents
Verify program consistency and usage of data, analysis and submission standards across clinical trials
Collaborate with biostatistics, data management, pharmacovigilance and clinical to provide programming support
Qualification
Required
Bachelor's degree required
7+ years of experience in SAS programming
Expert proficiency, complete knowledge and understanding of statistical programming processes, procedures, and roles
Experience with CDISC SDTM and ADaM models including transforming raw database files while adhering to those standards
Demonstrated knowledge of the lifecycle of clinical data projects
Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a Windows environment with a demonstrated mastery of SAS/STAT procedures
Experience in organizing BLA, NDA/s NDA regulatory submissions
Extensive experience and proven ability in the use of SAS within a statistical computing environment to develop and validate statistical deliverables
Demonstrated knowledge of regulatory requirements for statistical programming deliverables and the regulatory submission process
Experience in developing and implementing SOPs
Possess a thorough knowledge of medical terminology and the clinical trial process including knowledge of biostatistics, data management, pharmacovigilance and clinical operations functions
Proficient in developing requests for proposals for external vendor contracts and in evaluating external vendor capabilities
Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company
Demonstrate effective time management and organizational skills including the ability to work under deadlines and on multiple projects simultaneously
Preferred
Master's degree or PhD in biostatistics (or related discipline) preferred
Benefits
Company-sponsored medical, dental, vision, life, long and short-term disability insurances
Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
401K participation with matching contributions
Employee Stock Purchase Program
Company
Wave Life Sciences
Wave Life Sciences is a clinical-stage RNA medicines company committed to delivering life-changing treatments for people battling diseases
H1B Sponsorship
Wave Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (11)
2023 (15)
2022 (16)
2021 (15)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$1.22BKey Investors
GlaxoSmithKlineTakeda VenturesForesite Capital
2025-12-09Post Ipo Equity· $350M
2024-09-24Post Ipo Equity· $200M
2023-12-06Post Ipo Equity· $100M
Leadership Team
Recent News
2026-01-06
2026-01-05
Company data provided by crunchbase