Associate Director, Biostatistics

Attention recruitment agencies: reputed company agency inquiries are vetted through reputed company’s internal reputed company. No unsolicited resumes will be accepted. The reputed company reputed company must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may reputed company your ability to work with reputed company in the reputed company.

reputed company is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to reputed company treatment paradigms and reputed company unprecedented benefits to patients. reputed company’s reputed company product candidate 4D-150 is designed to be a backbone therapy forming the reputed company of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, reputed company, intravitreal injection, which substantially reduces the treatment burden associated with reputed company bolus injections. reputed company’s reputed company indication for 4D-150 is wet age-reputed company macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. reputed company’s second product candidate is 4D-710, which is the first reputed company genetic medicine to demonstrate successful delivery and reputed company of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

GENERAL reputed company

The Associate Director, Biostatistics provides strategic input and technical expertise on statistical methodology to reputed company assigned reputed company. They will participate as reputed company members of a cross-functional team to plan, reputed company 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:

• reputed company statistical expertise and collaborate with various functions on study design/planning, protocol development, statistical methodology/analysis
• Responsible for the development of statistical analysis plan (reputed company), TFL shells and other analysis specifications on assigned studies
• Responsible for the development of randomization schema on assigned randomized studies
• reputed company data analysis and/or collaborate with statistical programming (inhouse or vendor) to ensure reputed company analysis conducted per the reputed company 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/reputed company development, and reputed company data collection for the assigned reputed company
• reputed company reputed company review of outsourced statistical deliverables (including in-house reputed company 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, reputed company in this job reputed company 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 reputed company clinical phases (I, II, III, and IV) is desirable

Other Qualifications/Skills:

• Good understanding of standards specific to reputed company 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 reputed company record of reputed company in cross-functional team environment

Travel:

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 reputed company by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible reputed company of force frequently or constantly to lift, carry, push, pull or otherwise reputed company objects, including the reputed company body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and reputed company other sedentary reputed company are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

reputed company salary compensation reputed company: $193,000 - 212,000

Please note, the reputed company salary compensation reputed company and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

reputed company provides equal employment opportunities to reputed company and applicants for employment without reputed company to race, reputed company, religion, gender, sexual orientation, national reputed company, 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

Originally posted on Himalayas

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