- Documentation review
- Analysis skills
- Communication skills
Xogene is a leader in innovative technologies and expert services to meet global clinical trial transparency requirements for the Life Science/Biotech industries. Since 2010, Xogene has been offering a suite of transparency services to meet evolving regulatory needs, from helping to build a newly emerging transparency capability to augmenting an already mature process.
Combining deep transparency expertise with a modern technology stack, Xogene also provides software solutions to automate processes and track myriad studies, regulations and statuses.
Our expertise ranges from clinical trial registration and results reporting, document redaction and lay summary development, to SAS/XML support, data sharing, online study tracking solutions, and building/hosting websites.
Xogene is headquartered in New Jersey with offices in Vienna, Austria and Gurgaon and Pune, India. For more information, visit us at http://www.xogene.com.
Xogene is looking for individuals with strong analytical skills for the Bio-Statistics Programmer (“Programmer”) role in Clinical Trial Transparency. This position requires a strong understanding and processing of clinical datasets, documents and techniques to ensure that the publications of scientific research and information comply with global privacy laws. The Programmer will be part of a dynamic and innovative tech team and will be challenged to work with complex data from various sources for de-identification in accordance with data privacy regulatory policies including Canada PRCI and EMA.
KEY TASKS AND RESPONSIBILITIES
Maintain and keep up with regulatory policies on protection of personal information
Develop strong understanding of clinical trial life cycle, data collected and how they are used in authoring of various clinical documents and publications
Use statistical programming for de-identification of clinical documents and datasets
Analyze and measure risk of re-identification of anonymized data
Perform related calibration and testing
Work closely with the product tech team as SME on anonymization and de-identification
Contribute to or lead the statistical programming thinking, analysis and reporting to relevant groups in product and study teams
Development of standard methodology to improve quality, efficiency and effectiveness
Strong understanding of clinical study data, documents, and results
Experience working with clinical datasets and creating Clinical Study Reports
Strong programming skills in SAS, R and/or similar statistical/database language and knowledge of XML
US Work Authorization
Master’s degree in life sciences and/or computer science or equivalent experiences
Excellent analytical, communication and presentation skills
Strong interest in technology and/or life sciences
Strong organizational skills and self-starter
Strong proficiency with Microsoft Office programs
Work or research background in life sciences, and/or pharmaceutical industry plus+