A Biostatistics Manager or Director manages a team of statisticians and directs statistical analysis and reporting of health and biology-related data. Analysis may be used for product development at a pharmaceutical company, disease research at a hospital or health policy research at a public health organization. Directs the design of statistical analysis and reviews analysis and findings; may manage regulatory reporting for projects such as clinical trials.
Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future. 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
QUALIFICATIONS
Education:
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, Med
DRA, 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:
$193,000•212,000 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
