• Conduct coverage reviews using critical thinking and clinical expertise. • Interpret benefit language and policies to guide clinical coverage determinations. • Document clinical review findings and outcomes in compliance with organizational standards. • Engage in peer-to-peer consultations with prescribing providers. • Collaborate and communicate effectively with fellow Medical Directors. • Schedule 40 hours per week, either 5 shifts of 8 hours or 4 shifts of 10 hours.

Role Description The gBDS / Med Data/AI, Boehringer Ingelheim is seeking a Postdoctoral Research Fellow to help advance the development of robust clinical trial simulation tools aimed at improving the probability of success for clinical trials by integrating multimodal datasets. This is an applied research and implementation role—focused on evaluating rigorous statistical methodology from the research stage into confirmatory, pivotal clinical studies. It is an exceptional opportunity for candidates looking to bridge academia and industry from a clinical statistical research perspective, working at the intersection of methodological rigor and real-world drug development impact. The fellow will focus on identifying, integrating, and applying fit-for-purpose methods and data to inform trial design and execution decisions—supporting faster, more reliable studies through improved feasibility assessment, operational risk forecasting, and robust inference under real-world trial constraints. This research role emphasizes reproducible methods, transparent assumptions, and publication-quality statistical work that can be translated into practical tools used by clinical development teams. The ideal candidate is self-driven and motivated—someone who works independently and takes initiative, while benefiting from scientific guidance and a collaborative team environment. Duties & Responsibilities - Integrate multimodal data sources across trial operations and clinical outcomes to parameterize and calibrate simulations (internal trial data + operational metrics + external benchmarks where appropriate). - Evaluate and validate clinical trial simulation frameworks that quantify how operational and clinical factors (e.g., recruitment pace, dropout, missing data, site heterogeneity, nonadherence, endpoint variability, protocol deviations) impact probability of success. - Build simulation models incorporating relevant data sources (clinical trial, real world evidence) for scenario basis planning, and integration via simulation. - Build scenario engines for trial execution planning (e.g., “what-if” analyses on site mix, monitoring intensity, recruitment strategies, data cleaning rules, visit schedules, or enrichment approaches) and translate results into actionable decision support. - Implement and compare statistical methods relevant to trial robustness under execution realities, including: - missing data mechanisms and sensitivity analyses (MAR/MNAR), - Bayesian models (meta analytic, hierarchical, etc.), - intercurrent events and estimands-aligned strategies, - site-level/random effects and cluster heterogeneity, - treatment effect attenuation due to nonadherence, - informative dropout and time-varying covariates. - Conduct simulation studies to evaluate design choices (sample size, randomization schemes, interim decision rules, adaptive elements, endpoint definitions) and make predictions using performance metrics such as power, type I error, bias, estimation bias, predictive probabilities, and other operating characteristics. - Create reusable, reproducible simulation pipelines (R/Python) for simulation, diagnostics, and reporting—version-controlled, well-tested, and well-documented for long-term sustainability. - Communicate results clearly to cross-functional stakeholders (biostatistics, clinical operations, clinical development, data science) via manuscripts, conference abstracts, internal whitepapers, and presentations. Qualifications - Ph.D. in Biostatistics or Statistics (or closely related quantitative discipline) from an accredited institution, awarded prior to start date. - Strong foundation in clinical trial methodology and inference (e.g., GLMs, mixed models, survival analysis, longitudinal models, causal/estimand thinking, multiplicity basics, Bayesian experience). - Demonstrated ability to program in R and/or Python for statistical modeling and simulation; experience with reproducible workflows (Git, unit testing, code review, literate reporting such as Quarto/RMarkdown/Jupyter) preferred. - Familiarity with Monte Carlo simulation, power/operating characteristic evaluation, and principled model checking/validation. - Interest or experience working with multimodal trial data including operational metrics (site performance, enrollment curves, deviations) and clinical outcomes data; experience with real-world or observational health data is a plus but not required. - Ability to work in a highly collaborative environment and communicate statistical results to non-statistical stakeholders with clarity and pragmatism. - Demonstrated capacity to work independently, manage your own research agenda, and roll forward on problems without waiting for constant direction—proactive initiative is a key expectation of this role. Eligibility Requirements - Must be legally authorized to work in the United States without restriction. - Must be willing to take a drug test and post-offer physical (if required). - Must be 18 years of age or older. Application Requirements - Curriculum vitae - Letter of intent - focusing on how a fellowship at Boehringer Ingelheim can help further your career growth. *Please upload under My Documents, Additional Attachments. Compensation This position offers a base salary of $80,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Duration Two years Location Remote (within US)

Role Description The gBDS /Med Data/AI -- Boehringer Ingelheim is seeking a postdoctoral research fellow to help leverage scientifically rigorous digital health technologies that accelerate clinical development across therapeutic areas. The fellow will drive innovation in digital endpoints, remote monitoring technologies, and multimodal data analytics to enhance multiple facets of clinical trials: - Identifying and recruiting suitable patients - Capturing meaningful real-world outcomes such as quality of life, functional capacity, and disease progression This research-focused role emphasizes translating digital health innovations into deployable solutions that improve trial outcomes by better understanding patients’ journeys in the real-world setting. Work will be anchored in Boehringer Ingelheim’s core therapeutic areas — e.g. respiratory, cardiovascular-renal-metabolic, oncology, CNS — with digital measures selected/evaluated in the context of clinically meaningful endpoints for those disease areas. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees. Duties & Responsibilities - Under supervisor/s guidance, lead research focused on evaluating, testing, and deploying digital health technologies (wearables, sensors, smartphone apps, patient-reported outcomes) to accelerate clinical development as well as manuscript preparation and submissions. - Conduct statistical analysis of multimodal real-world behavioral data to assess associations with key clinical outcomes of interest (e.g., treatment response, disease progression, adherence, data quality, patient phenotypes/stratification, digital endpoint validation, quality of life). - Proactively design and lead the development of reusable, reproducible data analysis pipelines for extracting quality metrics, features, and validated digital endpoints from multimodal clinical trial data. - Design and execute validation studies to establish the scientific rigor, reliability, and clinical meaningfulness of digital health measures for trial use (e.g., patient identification/screening, enrollment optimization, quality-of-life assessment, functional outcomes). - Collaborate with interdisciplinary and cross-functional teams (clinical development, biostatistics, data science, clinical operations, regulatory affairs) to communicate and present research findings through presentations and scientific reports. Qualifications - Ph.D. from an accredited institution earned before the start date at Boehringer Ingelheim. Preferred degree in a quantitative field such as biomedical engineering, statistics, computer science, electrical engineering, data science, or a related discipline. - Demonstrable proficiency in at least one scripting language (Python or R preferred) and experience writing reusable, version-controlled (Git), and well-documented code. - Demonstrated scientific experience in digital health research as evidenced by publications, presentations, or successful digital health project implementations. - Strong background in applied data science, signal processing, time-series analysis, and machine learning/statistics, preferably in healthcare or clinical research domains. - Experience analyzing temporal health-related data from digital health applications, wearable/smartphone sensors (e.g., accelerometer, activity, sleep, voice or other physiological/behavioral measures) is strongly preferred. - Familiarity with clinical outcome assessment (COA) frameworks and patient-centered measurement, including PRO, ClinRO, ObsRO, and PerfO categories; experience with ePRO/eCOA instruments or FDA PRO Guidance concepts is a plus. - Excellent interpersonal, communication, and presentation skills with the ability to work effectively in a dynamic, collaborative, and cross-functional environment. - Working knowledge of regulatory frameworks relevant to digital health technologies, including FDA DHT/SaMD guidance, ICH E6 (GCP), and digital endpoint evidentiary standards (e.g., V3+, BEST Resource, DDT qualification pathway); is a plus. Requirements - Must be legally authorized to work in the United States without restriction. - Must be willing to take a drug test and post-offer physical (if required). - Must be 18 years of age or older. Benefits - Compensation: This position offers a base salary of $80,000. The position may be eligible for a role-specific variable or performance-based bonus and/or other compensation elements. - Duration: Two years. - Location: Remote (within US).

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Director, Medical Safety Lead - DSPV Gene Therapy to help us expand what’s possible for patients with serious diseases. Reporting to the Sr Director, DSPV Gene Therapy Safety Lead, the Director, Medical Safety Lead serves as the DSPV subject matter expert for assigned products, maintaining deep and up-to-date knowledge of the product portfolio and associated safety profiles. This role is responsible for safety surveillance, risk management, and risk communication across assigned development and marketed products. It includes medical evaluation of individual adverse event reports, oversight of aggregate report generation and safety documentation, and collaboration on labeling updates. The position also provides expert DSPV support to both internal and external stakeholders. What You'll Do: In this role, you’ll have the opportunity to review all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds. You’ll also: - Conduct safety signal detection activities, monitoring, evaluation, interpretation, and appropriate management and communication of safety information. - Lead the Safety Review Team(s) for assigned products and development compounds and manage the ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents. - Provide medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs). - Work with the DSPV leadership to develop the strategy and implementation of safety and benefit-risk management for assigned products; develop key content of Risk Management documents (RMPs, REMS) for assigned products. - Provide input into the writing of periodic reports for assigned products; provide medical interpretation, review, and approval for required reports. - Share DSPV and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal. - Provide expert safety input to the clinical development program for assigned products and development compounds. - Ensure, in collaboration with Regulatory Affairs labeling team an accurate representation and communication of the safety profile of assigned products and development compounds. - Provide integrated safety input into all regulatory documents, thorough assessment of safety profiles for Due Diligence projects, and provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters. - Respond to inquiries from regulatory authorities on safety issues. Who You Are: You must have an MD or DO with 5+ years of experience in Drug Safety/Pharmacovigilance within a pharmaceutical industry setting across both investigational and marketed products. Additionally, you have: - Experience reviewing and preparing scientific or regulatory documents from large volumes of scientific information. - Knowledge and understanding of national & international Pharmacovigilance and regulatory guidelines. - Experience presenting drug safety topics for regulatory authorities or at conventions, meetings, etc. - Impeccable communication skills, both verbal and written. - Excellent organizational skills with a strong attention to detail, clarity, accuracy, and conciseness. - Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace. Nice to have (but not required): - Master of Public Health (MPH) is a plus. - 2+ years’ experience in Clinical Patient Care is strongly preferred. - Drug safety database knowledge is preferred. - Experience working on gene therapy products is a plus. - Product defense before a national or international regulatory authority a plus. Where You’ll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected. Travel Requirements This role requires occasional domestic travel (up to 20%). #LI-MM1 #LI-Remote Pay Range: $247,000.00-337,000.00 Annual Life at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: - Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) - Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration - 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance - Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities - Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.  Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled. For New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review. If you are an applicant for this role and a New York City resident, you have the right to request: - A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or - An alternative selection process by emailing Privacy@insmed.com. - Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.