Executive Director, Statistical Programming

• →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.

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, and time management skills, with strong attention to detail and the ability to lead multiple complex priorities in a fast-paced environment with shifting timelines and competing demands
• Excellent written and verbal communication skills, with the ability to influence senior stakeholders and communicate complex technical information clearly across functions
• Proven conceptual, analytical, strategic, and enterprise-level thinking
• Strong interpersonal, vendor oversight, people leadership, and project management skills
• Proactively identifies risks, issues, and possible solutions, and drives timely decision-making, escalation, and resolution

Travel: <5%

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $298,000 - $340,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.