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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 Sr Manager, Statistical Programming provides technical leadership for statistical programming activities for a given clinical development program. 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 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.
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 post‑hoc 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
- 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
- Participate in CRO selection, contracting, and performance evaluation.
- Ensure vendor deliverables meet agreed timelines, quality standards, and contractual obligations.
QUALIFICATIONS:
Education:
- Master’s or PhD in Statistics, Biostatistics, Mathematics, Computer Science, or related field (BS with significant experience considered).
Experience:
- 7+ years of statistical programming experience in pharmaceutical, biotechnology industry w/ Bachelors. 4+ years w/ Masters. 3+ 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
Other Qualifications/Skills:
- Excellent communication, problem‑solving, and project management skills.
- Ability to manage multiple priorities in a fast‑paced, matrixed environment.
Travel: 10%
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: $154,000 - $179,000
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.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
