Director, Biostatistics

Описание вакансии

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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 incumbent provides strategic statistical input to and oversees all statistical aspects of assigned programs; drives cross-functional collaboration and decision making for program(s); oversees the performance of Contract Research Organizations (CROs); develop and mentor other statisticians. 

 MAJOR DUTIES & RESPONSIBILITIES: 

• Ensures expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, influence and implement publication strategy, quantitative decision making) for critical studies in a program

• Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enables successful impact on robust drug development plans

• Maintains indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results.

• Provides 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 participates in the development and review of Policies, SOPs and other controlled documents for process improvement and operational efficiency.

• Supports the preparation and validation of statistical analyses for use in regulatory documents and scientific articles. Support internal ad-hoc and exploratory analysis.

• Plays a critical role in shaping team development and contributing to departmental strategy.

• Stays abreast of and contributes to 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:  

• M.S. required

• PhD preferred

 Experience:  

• 8+ years of pharmaceutical industry experience with a PhD, or 10+ years with an MS.

• Hands-on familiarity with common and advanced statistical methodology.

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

 Other Qualifications/Skills:  

• Strong knowledge of SAS programming concepts and techniques in the pharmaceutical; proficiency in tools such as SAS, EAST, and nQuery.

• Knowledge/experience of Retinal development, including global regulatory requirements and design and analysis of non-inferiority trials

 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: $276,000 - 319,000 

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