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GENERAL SUMMARYThe 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, 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:
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.
