Associate Director, Statistical Programming

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.

 

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

GENERAL SUMMARY

The Associate Director, Statistical Programming provides technical leadership and operational oversight for statistical programming activities across multiple clinical development programs. This role is accountable for the accuracy, quality, and timeliness of programming deliverables for clinical trial reporting, integrated safety/efficacy analyses, and global regulatory submissions. The position also drives the development and maintenance of programming standards, SOPs, and tools, and ensures compliance with CDISC standards, ICH GCP, and applicable regulatory requirements. The incumbent will collaborate closely with cross functional teams and external vendors and may manage and mentor programming staff.

 

MAJOR DUTIES & RESPONSIBILITIES:

 

Programming Leadership & Delivery

• 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.

Regulatory & Submission Readiness

• 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).

Process & Standards Development

• 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.

Cross Functional Collaboration

• 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.

Team & Vendor Management

• 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.

QUALIFICATIONS: 

Education: 

• BS in Statistics, Biostatistics, Mathematics, Computer Science, or related field with significant experience required.
• Master’s or PhD preferred.

Experience: 

• 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