Associate Director, Statistical Programming

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November 13

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4D Molecular Therapeutics

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4DMT is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market and rare diseases. Our vector discovery platform Therapeutic Vector Evolution harnesses the power of directed evolution, a Nobel Prize-winning technology, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors with improved therapeutic profiles compared to wild-type vectors. Our product design, development and manufacturing engine empowers us to efficiently create our valuable and diverse product pipeline. This combination of bold innovation and relentless execution gives 4DMT the capability to revolutionize genetic medicines and to strive for potential curative therapies. We have built a deep portfolio of genetic medicine product candidates, with five product candidates in clinical trials for seven patient populations.

51 - 200 employees

📋 Description

• 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 postdoc 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). • Develop and maintain programming SOPs, guidelines, macros, and reusable tools. • 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. • Manage internal programming resources and mentor junior staff. • Participate in CRO selection, contracting, and performance evaluation. • Ensure vendor deliverables meet agreed timelines, quality standards, and contractual obligations.

🎯 Requirements

• BS in Statistics, Biostatistics, Mathematics, Computer Science, or related field with significant experience required. • Master’s or PhD preferred. • 9+ years of statistical programming experience in pharmaceutical, biotechnology industry w/ Bachelors. 7+ years w/ Masters. 4+ 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. • Experience in ophthalmology preferred. • Excellent communication, problem-solving, and project management skills. • Ability to manage multiple priorities in a fast-paced, matrixed environment.

🏖️ Benefits

• Equal employment opportunities to all employees and applicants. • No discrimination based on race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, or any other category protected by law.