Associate Director, Biostatistics

BioSpace; United States; On-site; USD 197,000 - 217,000; Full time

Job summary

4DMT, a leading biotechnology company, seeks an Associate Director of Biostatistics to provide strategic statistical leadership for ophthalmology and gene therapy programs. You will collaborate across functions to design studies, develop SAPs, and guide data analyses across multiple trial phases.

The role emphasizes strong communication, regulatory knowledge, and the ability to manage vendor relationships while advancing 4DMT’s pipeline in wet AMD and cystic fibrosis therapies.

Qualifications

• MS/PhD in Biostatistics or related field (or equivalent experience).
• 7+ years in biotech/pharmaceutical industry with biostatistics focus (MS); 4+ years with PhD.
• Experience in ophthalmology and/or biologic/gene therapy is a plus.
• Experience across all clinical trial phases I–IV is desirable.
• Good understanding of GCP/ICH guidelines and regulatory standards.

Responsibilities

• Provide statistical expertise for study design, SAPs and analysis plans.
• Lead development of randomization schema for randomized studies.
• Analyze data and collaborate with programming vendors to ensure quality analyses.
• Prepare statistical reports and ensure accurate data presentation for reports/publications.
• Ensure robust CRF/EDC development and quality data collection for trials.
• Oversee outsourced statistical deliverables and internal QC reviews.
• Stay current with biostatistics developments and apply to processes.
• Other duties as assigned by management.

Skills

Biostatistics

Statistical analysis

Study design

Cross-functional collaboration

Communication

Education

MS/PhD in Biostatistics or related field

Tools

CDISC SDTM ADaM

MedDRA/WHODRUG

Job description

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, Biostatistics provides strategic input and technical expertise on statistical methodology to lead assigned projects. They will participate as active members of a cross-functional team to plan, lead and execute the tasks required to support the assigned programs. The incumbent will collaborate closely with cross-functional teams and external vendors.

Major Duties & Responsibilities

• Provide statistical expertise and collaborate with various functions on study design/planning, protocol development, statistical methodology/analysis
• Responsible for the development of statistical analysis plan (SAP), TFL shells and other analysis specifications on assigned studies
• Responsible for the development of randomization schema on assigned randomized studies
• Perform data analysis and/or collaborate with statistical programming (inhouse or vendor) to ensure quality analysis conducted per the SAP and specifications
• Responsible for the development of statistical reports summarizing the data analysis results
• Ensure adequate interpretation of data/analysis results and consistency/accuracy of data presentation for study reports and publications
• Collaborate with various functions to ensure robust CRF/EDC development, and quality data collection for the assigned clinical trials
• Provide quality review of outsourced statistical deliverables (including in-house double programming to QC as needed) and coordinate the in-house review comments
• Stay abreast of industry development in biostatistics/statistical programming fields and apply to appropriate systems and processes
• 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

QUALIFICATIONS

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

Experience

• A M.S. with 7+ years, or PhD with 4+ years in biotech/pharmaceutical industry
• Experience in ophthalmology and/or biologic/gene therapy a plus
• Experience with all clinical phases (I, II, III, and IV) is desirable

Other Qualifications/Skills

• Good understanding of standards specific to clinical trials such as CDISC, SDTM, and ADaM, MedDRA, WHODRUG
• Knowledge of applicable GCP/FDACHMP//ICH/HIPPA regulations
• Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a fast-paced environment with shifting priorities and/or conflicting deadlines
• Excellent written and verbal communication skills and strong team player with demonstrated track record of success in cross-functional team environment

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: $197,000 - 217,000

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