Our Ability Jobs

Employer Name: Yale University

1. Directs, monitors, and assesses needs and directs the application of resources of an administrative University office dealing with one or more major functional areas. 2. Directs and implements solutions to problems that are routine to complex in nature and that affect multiple functional areas of responsibility. 3. Plans and/or participates in planning University activities on a long-term basis to comply with University goals and objectives. 4. Establishes and implements consistent university-wide policies in multiple functional areas of responsibility. 5. Ensures that University office policies and procedures are in compliance with federal, state, and local laws and ordinances. 6. Develops and monitors goals and objectives for managerial and professional staff in compliance with University strategies. 7. Directs a staff of exempt and non-exempt employees. 8. May perform other duties as assigned. Required Skill/ability 1: Extensive experience working as a biostatistician and supporting clinical research at all phases (study start- up/activation, on-going management, study close-out, and regulatory submission). Ability to manage and lead a team. Required Skill/ability 2: Experience with Electronic Data Capture and SAS and/or other statistical programs. Knowledge Federal data compliance requirements preferred. Required Skill/ability 3: Experience in supporting study design such as selection of primary and secondary endpoints, sample size calculations, randomization methods, and generating randomization schemas. Required Skill/ability 4: Familiarity of FDA regulations and ICH statistical guidance. Knowledge of CDISC standards (CDASH, SDTM, ADaM). Required Skill/ability 5: Demonstrated professionalism including maturity, good judgment, and the ability to work with cross functional teams. The ability to work remotely; including an adequate workspace with internet access. Preferred Education: Master's degree and experience 10+ yrs supporting Biostatistical needs in clinical trials setting. SQL & SAS programming skills (Base, Macro, ODS). eCTD data submissions, FHIR, data integration from EHR systems (Epic)/other eSource data sources (Direct Data Capture, eCOA/ePRO). Reporting Clinical Trials Data to federal agencies to meet regulatory requirements (CT.gov, NIH, FDA). Work Week: Standard (M-F equal number of hours per day) Posting Position Title: Associate Director 4 University Job Title: Assistant Director of Applied Biostatistics Preferred Education, Experience and Skills: Master's degree and experience 10+ yrs supporting Biostatistical needs in clinical trials setting. SQL & SAS programming skills (Base, Macro, ODS). eCTD data submissions, FHIR, data integration from EHR systems (Epic)/other eSource data sources (Direct Data Capture, eCOA/ePRO). Reporting Clinical Trials Data to federal agencies to meet regulatory requirements (CT.gov, NIH, FDA). Bachelor's Degree in related field and eight years of experience or an equivalent combination of education and related experience.