Senior Data Scientist

Apnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., we are developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders, including through Shionogi Apnimed Sleep Sciences, a joint venture with Shionogi, Inc. The Senior Data Scientist plays a critical role in the Data Analytics team, responsible for performing core data activities including overseeing the collection, processing, and quality assurance of large datasets to ensure accuracy and reliability, performing data analysis at both the individual and aggregate levels, and participating in internal and external reporting. This position will be focused on performing safety analysis to ensure the well-being of patients in the study, as well as efficacy analysis to support the company in their efforts to submit a New Drug Application (NDA) to the FDA. The Senior Data Scientist additionally reviews relevant literature for data insights, trend detection, and to support overall business activities and strategic decision-making. The Senior Data Scientist will report to the Chief Scientific Officer and may be based at Apnimed headquarters in Cambridge, Massachusetts, or remotely with travel to the home office as needed. Key Job Duties include, but are not limited to: Safety Data Analysis and Recommendations: Analyze and summarize safety data from ongoing and completed studies, providing actionable insights and recommendations at both the individual participant and aggregate levels. Signal Detection Strategy Development: Design and implement tailored signal detection strategies for assigned products to identify and evaluate safety signals effectively. Data Visualization and Analytics: Utilize data analytic and visualization tools to represent, explain, and document complex safety information in near real-time. Efficacy Data Analysis: Collaborate with the Data Analytics team to conduct efficacy analysis to support the companys NDA submission to the FDA. Safety Report Preparation: Assist in the preparation and authoring of individual and aggregate safety reports, ensuring accurate, timely, and high-quality contributions for regulatory submission documents (e.g., ISS, ISCRs, aggregate safety reports). Regulatory Submission Collaboration: Contribute to writing and reviewing safety and pharmacovigilance content for regulatory submissions and responses, collaborating with cross-functional teams as needed. Develop and maintain dashboards and reports to effectively communicate data findings to stakeholders. Qualifications: Master's or Ph.D. in Data Science, Computer Science, Statistics, Mathematics, or a related field. Minimum 6 years of relevant pharmaceutical experience. Minimum 8-10 years experience in data science, analytics, or a related field. Proficiency in programming languages such as Python, R, or SQL. Experience in implementing and reviewing cumulative data with ability to interpret, synthesize and communicate complex information, including use of data analytic and visualization tools such as Empirica, LifeSphere, JMP Clinical, Tableau, Power BI, or equivalent. Demonstrated ability to develop, execute and follow-through complex projects to completion Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view In-depth knowledge of Good Clinical Practice (GCP) and regulatory requirements Independently motivated, detail oriented and strong problem-solving ability Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities Excellent written and verbal communication skills with the ability to interact across multiple functions What Apnimed Offers: 401(k) with company match Generous time off for vacation Generous healthcare benefits Flexible working environment Motivated and experienced team Location and Other Information: Apnimed is a privately held company based in Cambridge, MA; we are generally virtual, and specific location within the US is flexible, but must be able to travel as necessary. Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment. Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea