Executive Director, Statistical Programming

About this role

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 Executive Director of Statistical Programming will provide strategic and operational leadership for statistical programming across assigned development programs. The role will apply deep programming expertise to guide in-house deliverables, ensure rigorous quality review of outsourced statistical deliverables, and establish scalable standards and processes. They will serve as a senior member of cross-functional teams, partnering with Biostatistics, Data Management, Clinical Development, Regulatory, Clinical Operations, Quality, IT, and external vendors to plan, prioritize, and execute activities supporting program and organizational objectives.

MAJOR DUTIES & RESPONSIBILITIES:

• Provide strategic and operational statistical programming leadership for assigned indications and development programs that may consist of multiple clinical trials and submission deliverables

• Partner closely with biostatisticians and cross-functional stakeholders to review statistical analysis plans and ensure development of clear, fit-for-purpose data and analysis programming specifications

• Ensure complete, auditable, and inspection-ready programming documentation for clinical trial analyses and regulatory submissions

• Lead the development, governance, documentation, and maintenance of reusable programming code, standards, templates, and best practices

• Partner with IT and functional leadership to define and maintain fit-for-purpose statistical computing infrastructure, including the SAS server environment and related tools

• Provide senior statistical programming expertise and, as needed, biometrics leadership on select projects and cross-functional initiatives

• Collaborate with various functions to ensure robust CRF/EDC development, and quality data collection for the assigned clinical trials

• Oversee biometrics vendors and external programming partners to ensure timely, high-quality statistical deliverables, effective issue escalation, and clear accountability

• Ensure quality review of outsourced statistical deliverables, including in-house double programming or quality control as needed, and coordinate internal review comments and resolution

• Lead or contribute to the development of function-level standards, SOPs, work instructions, templates, and continuous improvement initiatives

• Stay abreast of industry developments in biostatistics, statistical programming, regulatory expectations, automation, and data standards, and apply relevant advancements to systems and processes

• Establish programming strategy, resource priorities, quality expectations, and risk mitigation plans, and communicate key decisions and escalations to senior stakeholders

• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

QUALIFICATIONS:

Education:

• A./B.S. degree in statistics, computer science, or other quantitative science major required

• Advanced degree (M.A./M.S.) preferred, or equivalent experience

Experience:

• 17+ years of relevant statistical programming, biometrics, or clinical development experience, including significant leadership experience in clinical development and regulatory submissions

• Demonstrated experience leading statistical programming strategy and execution for regulatory submissions, including BLA/IND or equivalent global health authority submissions

• 8+ years of management experience, including scale-up of in-house programming team

• Experience in ophthalmology and/or biologic/gene therapy a plus

Other Qualifications/Skills:

• Expert SAS programming skills required, with proficiency in SAS/BASE, SAS Macros, SAS/STAT, and ODS; proficiency in SAS/SQL, SAS/GRAPH, or SAS/ACCESS is a plus

• Proficiency in R programming a plus

• Proficiency in Microsoft Office Apps, such as WORD, EXCEL, and PowerPoint (familiar with the “Chart” features in EXCEL/PowerPoint a plus)

• Strong understanding of standards specific to clinical trials, including CDISC, SDTM, ADaM, CDASH, MedDRA, and WHODrug

• Experience with all clinical phases (I, II, III, and IV) is desirable

• Experience leading or overseeing BLA/IND submissions is strongly desirable

• Good understanding of regulatory requirements for submission-related activities (e.g., CDISC, CDASH, eCTD) and CRT packages (e.g., XPTs Define/xml, reviewer’s guide, analysis metadata report, executable programs) is desirable

• Able to run the P21 checks is a plus

• Knowledge of applicable GCP/FDACHMP//ICH/HIPPA regulations

• Displays excellent organization, prioritization,…