Data Analyst, Clinical

This position will be required to interact with both English-speaking customers and Japanese-speaking customers. Flexibility in working hours will be expected as needed to support effective communication with customers in Japan.

Responsibilities

• Perform the technical configuration of the CluePoints solution for clinical studies based on customer requirements


• Perform analyses using the CluePoints Central Monitoring Platform – diagnosing and explaining anomalies identified in the clinical study data


• Summarize findings and support the communication of results to customers (both written report and oral presentation)


• Participate in the continuous improvement and development of our product solutions and operational processes


• Provide consultation and related operational support to customers as needed, with the help of more senior Data Analysts and/or the CluePoints Project Manager as well as mentoring more junior Data Analysts as needed


• Ensure that appropriate documentation is produced and maintained for each study


• Support and participate in developing and improving training material used both internally and externally as well as providing both on-site and off-site training to customers


• And finally, assist Business Development and Quality Assurance teams in responding to client questions and requests (e.g., RFP responses, audits, etc.)

Skills Needed

• Experience with one or more programming languages, including SAS


• Experience with and understanding of clinical trials and clinical data


• Aptitude for mathematical and statistical concepts and data analytics


• Excellent oral and written communication skills: fluent in both Japanese and English (business level – oral and written communication)


• Experience and ability to work well in a team environment


• Ability to thrive in a fast-moving environment, under time and resource constraints


• High degree of accuracy and attention to detail


• Experience in delivery of technical solution trainings is a plus


• Experience with CDISC databases is a plus

Qualifications Needed

• College degree, preferably in a scientific or technical discipline


• 2+ years of experience in a clinical research environment


• Knowledge of industry regulatory and clinical data standards including 21 CFR Part 11, ICH E6 (GCP), CDISC standards, MedDRA, WHODRUG, etc.