Executive Director, Statistical Programming
- each duty.
Qualifications: need to include Education, Experience, Other Qualifications/Skills. Could be
- each bullet? But Education and Experience are not list items; they are headings inside qualifications. However we are not allowed to use headings inside? We could just make a list where each item is a sentence. But we need to preserve the structure: Education: A./B.S. degree ... Advanced degree ... Experience: 17+ years ... Demonstrated experience ... etc. Other Qualifications/Skills: list of skills.
We could make a
- where each
- contains a heading like Education: ... but that adds extra markup not prohibited. The instruction only says use
- for any list of duties/requirements/benefits, and
for prose. It doesn't forbid other markup inside
- . So we can embed bold.
Thus we can create a
- for qualifications with three items: Education, Experience, Other Qualifications/Skills. Each item contains the details.
Pay:
Base salary compensation range: $298,000 - $340,000. Also note about factors. We must not include boilerplate like EEO etc. Now extract exact text. Company description paragraph: "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." Now duties list. Let's copy each sentence after "MAJOR DUTIES & RESPONSIBILITIES:" until before "QUALIFICATIONS:". I'll extract: - 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. Now qualifications. Education: "A./B.S. degree in statistics, computer science, or other quantitative science major requiredAdvanced degree (M.A./M.S.) preferred, or equivalent experience" Note there is no space after required before Advanced. We'll keep as is but maybe add space for readability? Must preserve substantive information; adding a space is not changing meaning. Probably fine. Experience: "17+ years of relevant statistical programming, biometrics, or clinical development experience, including significant leadership experience in clinical development and regulatory submissionsDemonstrated experience leading statistical programming strategy and execution for regulatory submissions, including BLA/IND or equivalent global health authority submissions8+ years of management experience, including scale-up of in-house programming teamExperience in ophthalmology and/or biologic/gene therapy a plus" Again missing spaces. We'll preserve but maybe add spaces after periods? The original lacks spaces; we should keep exactly? The instruction: preserve ALL substantive information; do NOT invent or summarize away detail. Adding spaces is not inventing content, just formatting. Might be okay. Safer to keep as is but it's hard to read. I think we can add spaces for readability without altering meaning. I'll add a space after each period where missing. Other Qualifications/Skills: list: "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 plusProficiency in R programming a plusProficiency 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 WHODrugExperience with all clinical phases (I, II, III, and IV) is desirableExperience leading or overseeing BLA/IND submissions is strongly desirableGood understanding of regulatory requirements for submission-related activities (e.g., CDISC, CDASH, eCT
- for any list of duties/requirements/benefits, and
- contains a heading like Education: ... but that adds extra markup not prohibited. The instruction only says use
- each bullet? But Education and Experience are not list items; they are headings inside qualifications. However we are not allowed to use headings inside? We could just make a list where each item is a sentence. But we need to preserve the structure: Education: A./B.S. degree ... Advanced degree ... Experience: 17+ years ... Demonstrated experience ... etc. Other Qualifications/Skills: list of skills.
We could make a