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Manager, Biostatistics - Medical Affairs

$128.6k - $210k

BioSpace

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Biostatistics Medical Affairs team. This individual will be responsible for statistical support for oncology compounds within Medical Affairs. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & Where Work Location: Sleepy Hollow, NY or Tarrytown, NY 4 days per week on site 25% Travel may be required Discover Your Role As part of a collaborative medical affairs team, you will implement the statistical functions role in the oncology compounds medical impact plans. Together with medical directors, HEOR, medical writing, market access, and other colleagues within medical affairs, you will plan and execute evidence generation efforts, such as post-hoc analysis with innovative analytical approaches, respond to payer and reimbursement needs, review investigator initiated studies, and design and execute Phase IV studies as the study biostatistician, and ensure statistical rigor in all these duties. You will also work with fellow clinical development biostatisticians and programmers to deep dive into the clinical trial data for comprehensive understanding. You will be responsible for following departmental guidelines of collaboration, innovation, and intrinsic motivation. Working in a dynamic team with a wide range of interfaces, the role requires both strategic and operational skills combining innovative statistical thinking with a strong sense of business acumen, and excellent communication and interpersonal skills. Your manager will work with you to manage stakeholders, learn about oncology and the companys compounds, develop Regeneron cultural understanding, and general industry knowledge. Strong interest and motivation in exploring existing clinical trial data for post-hoc analysis and innovative idea investigations Experience with clinical trial design, including observational studies Exposure to oncology study endpoints and analysis techniques Strong communication skills to interpret, explain, and discuss results of complex statistical concepts and analyses to both technical and non-technical audiences. Desire to present and share results with internal and external stakeholders. Comfort with providing scientific/statistical input into study design, formulating novel methods to problem solving, and independently developing the statistical analysis plan to implement those solutions. Authored Statistical Analysis Plans (SAP) and Protocols Generated tables, listings, and figures for external communication use in publications/presentations and for internal purposes. Ability translate and apply relevant innovative statistical methodology to everyday work. Educate and disseminate knowledge throughout the organization for areas within the expertise of medical affairs. This Role Requires PhD / DrPH in statistics/biostatistics or related disciplines with >2 years experience in the pharmaceutical/biotech industry or MS degree in statistics/biostatistics with >7 years experience in the pharmaceutical industry as a statistician. Knowledge of drug discovery/development/life cycle management(LCM) and ability to integrate statistical concepts into drug discovery/development/LCM strategies Prior experience or knowledge of oncology is strongly preferred Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment. Demonstrated critical thinking skills, time management skills, and effective communication skills. Solid knowledge of statistical analysis methodologies, experimental and clinical trial design Ability to write code in at least one common statistical software is required (i.e. SAS, R, Python). Ability to read SAS code is required We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit For other locations, additional information will be provided during the recruitment process. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually) $128,600.00 - $210,000.00 #J-18808-Ljbffr BioSpace

Vacancy posted 4 days ago
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