Vice President, Biostatistics

4DMT; United States; On-site; USD 330,000 - 390,000; Full time

Job summary

4DMT is seeking an experienced head of biostatistics to provide enterprise-level statistical leadership across global development programs. You will drive quantitative decision making and collaborate with clinical, regulatory, and strategic teams.

You will oversee CROs, mentor statisticians and lead the development and review of policies and SOPs to improve efficiency and inspection readiness. Strong regulatory knowledge and leadership are essential.

Qualifications

• Hands-on familiarity with common and advanced statistical methodology.
• Experience with CDISC standards and programming based on raw datasets (SDTM/ADaM).
• 10+ years of management experience leading senior technical talent and people managers.

Responsibilities

• Provides executive-level leadership for strategy in the global development program.
• Leads collaborations with clinical, regulatory and strategic functions to drive quantitative decision making.
• Oversees CROs and delivers high-quality study deliverables on time and to standards.
• Develops and reviews Policies, SOPs and other controlled documents for process improvement.
• Contributes strategic statistical input in regulatory documents and scientific articles.
• Leads data generation strategy for podium presentations and payor discussions.
• Shapes team development and succession planning within the department.

Skills

Statistical methodology

SAS programming

Leadership/people management

Education

PhD in Statistics/biostatistics or related field

MBA/Master's with significant experience

Tools

SAS

EAST

nQuery

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 incumbent provides enterprise-level strategic statistical leadership and oversight across all statistical aspects of assigned programs and the broader Biostatistics function; drives cross-functional collaboration, quantitative decision making, and development strategy for program(s); oversees the performance of Contract Research Organizations (CROs); develops and mentors statisticians and people leaders, and acts as Head of Biostatistics when needed.

MAJOR DUTIES & RESPONSIBILITIES:

• Provides executive-level leadership and accountability for strategy (design, analysis/synthesis, interpretation and reporting, health authority response, publication strategy, and quantitative decision making) in the global development program
• Leads senior-level collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enable successful impact on robust drug development plans
• Provides strategic oversight and guidance to staff members within 4DMT and in CROs in completing high quality study deliverables according to agreed timelines following quality standards.
• Leads and/or sponsors the development and review of Policies, SOPs and other controlled documents for process improvement, inspection readiness, and operational efficiency.
• Provides senior strategic statistical input in regulatory documents and scientific articles.
• Leads data generation strategy for podium presentations and payor discussions.
• Plays a critical role in shaping team development, succession planning, and contributing to departmental and functional strategy.
• Stays abreast of, contributes to, and represents the organization on scientific advances in the field.
• 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:

• PhD in Statistics, biostatistics or related fields or Masters with significant experience

Experience:

• 14+ years of pharmaceutical industry experience with a PhD, or 15+ years with an MS.

• Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.

• 10+ years of management experience, including leadership of senior technical talent and people managers

Other Qualifications/Skills:

• Hands-on familiarity with common and advanced statistical methodology.
• Strong knowledge of SAS programming concepts and techniques in the pharmaceutical; proficiency in tools such as SAS, EAST, and nQuery.
• Knowledge/experience of global regulatory requirements in novel endpoints and rare diseases is a plus

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: $330,000 - 390,000

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