Biostatistician

Working Location: NATIONWIDE Workplace Flexibility: Field For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​​Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. ​Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy.  Learn more about Life at Olympus: https://www.olympusamerica.com/careers.Job DescriptionThis role reports directly to the Director, Data Management and Systems collaborating closely with MCA – Medical Affairs and Clinical Affairs – as well as Health Economics and Market Access (HEMA) to run biostatistics and data management in support of clinical evidence generation strategies across the Gastrointestinal Solutions (GIS) / Surgical & Interventional Solutions (SIS) business unit portfolio.  The individual is to provide support on clinical studies and RWE research with cross-functional teams including internal and external business stakeholders within MSA, across GIS and SIS business units, and within the broader Olympus organization, as appropriate.    This individual will also conduct and develop plans for evidence-based literature reviews and identification of secondary sources to support health economic claims. Job DutiesServe as a primary analyst for clinical studies and RWE research using multiple clinical trial data and healthcare administrative data in support value proposition, abstract/manuscript submission.Prepare research findings for publication in peer-reviewed journals, conference presentations, and other dissemination channels.Manage multiple research projects simultaneously, ensuring they are completed on time, within budget, and in compliance with regulatory guidelines.Design statistical analysis plans for clinical studies and observational studies. Lead the design of clinical (and when relevant pre-clinical) studies: define endpoints, sample size/power, randomization strategy, and statistical methodology in support of proposal and protocol development.Oversee contracted statistical service vendors and provide direction of project scope and timelines. Develop contingency plans as necessary with regards to data analysis. Perform ad-hoc research and analysis requests on a variety of projects for Olympus business priorities including different evidence generation programs.Ensure compliance with regulatory standards relevant to medical devices (e.g., FDA, EMA, PMDA), quality systems/SOPs, data integrity and audit readiness.Lead or contribute to process improvement initiatives in biostatistics (methodology development, standardisation across studies, best practices).Perform programming or review of statistical programs (SAS, R, or other statistical software) to select/manipulate/analyse data; conduct QC of statistical outputs.Interpret statistical results; collaborate with cross-functional teams (clinical operations, regulatory affairs, medical writing, data management) to translate results for regulatory, scientific and commercial stakeholders.Perform all other duties as may be assigned from time to time by Management. Job QualificationsRequired:Bachelor / Masters Degree in statistics/biostatistics, mathematics, Public Health or Health Care Services Research or related field is required.  Minimum of 6 years previous in pharmaceutical/medical device industries or health care services research is required.Previous experience in statistics and its applications to clinical trials or observational studies, in academy or industry.And understanding of medical device purchase decision-making in the US.  Proficiency in a statistical programming package such as SAS, RA strong work ethic to promote the development of life changing treatments for patients.Analytics skill set with experience in clinical studies or medical claims and other secondary data to generate patient safety, treatment efficacy and cost-effectiveness message is essential.  Strong interpersonal skills and ability to motivate and influence others.Strong verbal and written communication skills.   Ability to coordinate and manage multiple priorities in a changing environment with minimal supervision. Strong skills in data analysis and the effective presentation of results. Advanced computer skill proficiency in Excel and PowerPoint is necessary.Competencies: Critical thinking: Ability to provide detailed insight into potential health economics opportunities and challenges  Convincing and influencing skills: Ability to present information in a logical manner that address the need and concerns of the audience  Project management skills: Manage project goals timeline and milestones to assure on task deliverable schedules.Must be able to travel up to 10% of the time. Why join Olympus?We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.  Equitable Offerings you can count on:Competitive salaries, annual bonus and 401(k)* with company matchComprehensive medical, dental, vision coverage effective on start date24/7 Employee Assistance ProgramFree live and on-demand Wellbeing ProgramsGenerous Paid Vacation and Sick TimePaid Parental Leave and Adoption Assistance*12 Paid HolidaysOn-Site Child Daycare, Café, Fitness Center** Connected Culture you can embrace:Work-life integrated culture that supports an employee centric mindsetOffers onsite, hybrid and field work environmentsPaid volunteering and charitable donation/match programsEmployee Resource GroupsDedicated Training Resources and Learning & Development Programs Paid Educational Assistance *US Only**Center Valley, PA and Westborough, MA Are you ready to be a part of our team?Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.The anticipated base pay range for this full-time position working at this location is $100,000 - $160,000 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications. At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.  For more information, visit www.olympusamerica.com. You Belong at OlympusWe are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.  Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787). Let’s realize your potential, together.It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Research and Development