Data Scientist

Quantum Leap Healthcare Collaborative (QLHC) is seeking an exceptional Data Scientist with strong analytical and computational skills to support multiple complex clinical trials in Oncology and COVID. The Data Scientist is responsible for performing data analytical and programming activities in these trials, which may be Phase I, II and III pharmaceutical trials and medical device trials evaluating new biomarkers and/or therapeutics. The trials also involve real world evidence generation, patient reported outcomes (PROs) and analysis of complex big data sets. The ideal candidate will have 3+ years of relevant experience with advanced degree in computational sciences and strong project management skills.

GENERAL DUTIES AND ESSENTIAL JOB FUNCTIONS:

• Ensure accurate and timely completion of analytical and programming activities and output for assigned projects.
• Plan and execute on datasets to be analyzed, including exploratory activities or with pre-specified requirements.
• Explore and test creative solutions to solve complex data problems. Explore the fit-for-purpose usage of various software and analytical tools according to the scientific context of the projects. Exercise independent judgement and integrity in selecting and adapting, as necessary, methods appropriate for the specific objective.
• Ability to develop and complete innovative data projects. Apply analytical methods to diverse sources of data and share results in varying formats, including data manipulations, data visualization, and data engineering.
• Coordinates and produces data deliverables for pharmaceutical partners as needed.
• Prepares data reports, tabulations, and graphs for presentation at meetings or conferences, and for publication in technical journals.
• Perform verification and documentation of the results.
• Estimates programming time requirements for project timelines.
• Assists in developing and maintaining necessary standard operating procedures (SOPs) and work instructions to support the quality and timeliness of team deliverables.
• Remains current about new developments and standards in the field of Data Science and shares with the Statistics and Clinical Data Management team members.

Minimum Qualifications

• Master’s degree in Data Science, Mathematics, Statistics, Biostatistics, Bioinformatics, Biological Sciences, or related discipline.
• 3+ years of relevant work experience in industry or academia.
• Experience with phase I, II and III pharmaceutical clinical trials, preferably in trials whose data was submitted as part of an investigational new drug (IND) or new drug application (NDA) to the FDA.
• Oncology experience highly preferred.
• Strong project management skills. Ability to effectively collaborate with internal and external stakeholders.

Skills/Competencies

• Working knowledge of theoretical and applied computational methods, preferably in clinical trials and adaptive designs.
• Proficient programming and analytical skills, preferably in R and/or python.
• Strong project management skills. Strong problem-solving skills.
• Strong interpersonal and motivational skills.
• A self-starter, who excels in a fast-paced and dynamic work. Ability to take the initiative while operating effectively with peers.
• High attention to detail including proven ability to manage multiple, competing priorities. Ability to prioritize and drive to results with a strong emphasis on quality.
• Excellent oral, written and presentation skills.
• Excellent understanding of the business processes, GCP standards and software used in clinical trials, outcomes research and real-world evidence generation.
• Experience in managing vendors and consultants is a plus.
• Experience in different regulatory classifications (drug, medical device, and diagnostics) is a plus.