Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com
The Clinical Data Analyst uses programming, analytical and statistical methods to identify and characterize issues and trends in operational and patient clinical trial data. This position will be responsible for assembling data, developing reporting, and working with cross-functional teams to develop recommendations in support of clinical protocols. This individual will leverage operational experience and knowledge to evaluate issues and develop findings based on data analyzed and will communicate issues and potential risks to project team members for follow-up action.
- Independently reviews and analyzes clinical trial data using a variety of tools and systems in alignment with the centralized monitoring plan, flexing review assignments across the majority of different analyses
- Characterizes and tracks the evidence of issues, signals and potential risks (Example: KRI's, patient profiles...etc.)
- Performs complex and root cause analyses to connect related signal to risks, and ensure delivery of high-quality, on time results
- Programs/Analyzes data and information to measure performance and identify improvement opportunities
- Collaborates with project teams, Medical, Clinical Scientists, Clinical Project Management staff, and Statistical groups to identify key safety and quality issues
- Programs/Analyzes current and historical data using various predictive analytics techniques
- Collaborates with all internal teams to identify opportunities for greater efficiency and workflow improvement/automation
- Other duties may be assigned
- Bachelor's degree from a college/university in Math, Computer Science, or Statistics, required
- Master's degree preferred
- Five (5) years or more of experience in practical applications of modeling and simulation required
- Five (5) years or more of experience analyzing and interpreting large sets of data and drawing conclusions in order to make recommendations required
- Advanced proficiency in following platforms:
- Experience with risk-based monitoring platforms (i.e. CluePoints, Spotfire...etc.)
- Experience with one or more programming languages; statistical programming (SAS, R ...) required
- Experience with CDISC databases preferred - Clinical Data Interchange Standards Consortium
Other Important Information
- Experience in a clinical research organization, pharmaceutical organization, and/or evaluating data and safety trends strongly preferred
- Ability to organize, prioritize, and work effectively in a constantly evolving workplace
- Demonstrates high personal integrity, teamwork abilities, and ability to thrive in fast-paced environment
- Ability to define problems, collect data, establish facts, and draw valid conclusions with limited direction
- Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables
- Ability to multi-task under pressure
- Ability to read and interpret documents such as company policies, operating and maintenance instructions, procedure manuals, financial reports, and legal document.
- Excellent English oral and written communication skills
- Ability to read, analyze, and interpret common scientific and technical journals
The work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing duties of this job, the employee may or may not be frequently/or occasionally required to:
- Stand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell.
- Climb stairs or ride elevators.
- Lift and/or move up to 25 pounds.
- Use close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
- Manipulate keyboard or otherwise access computer, telephone and hand-held devices.
- Be exposed to outside weather conditions while going in and out of office buildings.
- Overnight travel is required for this position. Travel is estimated at 15%.