4D Molecular Therapeutics · 3 days ago
Senior Manager, Statistical Programming
Emeryville, CA
Full-time
Onsite
Senior Level
$154K/yr - $179K/yr
7+ years exp4D Molecular Therapeutics is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The Sr Manager, Statistical Programming provides technical leadership for statistical programming activities for clinical development programs, ensuring the accuracy and compliance of programming deliverables for regulatory submissions.
BiotechnologyGenetics
Responsibilities
Lead statistical programming activities for assigned programs, including oversight of CRO deliverables
Develop, review, and execute SAS programs to produce SDTM/ADaM datasets, tables, figures, and listings in accordance with SAPs
Perform quality control (QC) of programming deliverables to ensure accuracy, consistency, and compliance
Support ad hoc, exploratory, and post‑hoc analyses as needed
Prepare and standardize data packages for regulatory submissions (BLA, NDA, MAA), including ISS/ISE deliverables
Ensure CDISC compliance using implementation guides and validation tools (e.g., Pinnacle 21)
Review and approve dataset specifications, output shells, and reviewer’s guides (SDRG, ADRG)
Contribute to process improvement and standardization initiatives within the Biometrics function
Stay current with evolving regulatory requirements, industry standards, and emerging technologies
Represent Statistical Programming in internal and external meetings
Partner with Biostatistics, Data Management, Regulatory, and Clinical teams to align deliverables and resolve issues
Communicate technical concepts clearly to both technical and non‑technical stakeholders
Participate in CRO selection, contracting, and performance evaluation
Ensure vendor deliverables meet agreed timelines, quality standards, and contractual obligations
Qualification
Required
Master's or PhD in Statistics, Biostatistics, Mathematics, Computer Science, or related field (BS with significant experience considered)
7+ years of statistical programming experience in pharmaceutical, biotechnology industry w/ Bachelors. 4+ years w/ Masters. 3+ years w/ PhD
Expert proficiency in SAS (Base, Macro, Stat, Graph, ODS); working knowledge of R or Python preferred
Deep knowledge of CDISC SDTM/ADaM standards, metadata, and regulatory submission requirements
Experience with Pinnacle 21 and preparation of reviewer's guides
Strong understanding of clinical trial design, data collection, and reporting processes
Experience in Gene Therapy
Excellent communication, problem‑solving, and project management skills
Ability to manage multiple priorities in a fast‑paced, matrixed environment
Preferred
Working knowledge of R or Python
Experience in ophthalmology
Company
4D Molecular Therapeutics
4D Molecular Therapeutics designs, develops, and commercializes transformative gene therapeutic products for unmet medical conditions.
51-200 employees
H1B Sponsorship
4D Molecular Therapeutics 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 (1)
2024 (3)
2023 (1)
2022 (1)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
$702.5MKey Investors
Cystic Fibrosis FoundationViking Global Investors
2025-11-06Post Ipo Equity· $100M
2025-10-13Post Ipo Equity· $7.5M
2024-02-06Post Ipo Equity· $300M
Leadership Team
David Kirn
Co-Founder & CEO
L
Liansheng Zhu
Sr VP Biometrics and Data Quality
Recent News
2026-01-07
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2025-12-19
Benzinga.com
2025-12-19
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