Senior Manager, Biostatistics - Medical Affairs

<p>Regeneron is seeking a Senior Manager, Biostatistics - Medical Affairs to join our team!</p><p></p><p>The Senior Manager of Biostatistics <span>will be responsible for statistical support for </span>Immunology &amp; Inflammation <span>within Medical Affairs </span>and cultivate strong partnerships to enable effective cross-functional collaboration with other product team members from internal groups including BDM, Medical Affairs/HEOR, Clinical Development, Regulatory Affairs and other functions as needed.  In addition, the Senior Manager of Biostatistics will support collaborations with external partners (e.g. CROs, industry consortiums, key opinion leaders). They will work with the Medical Affairs Biostatistics therapeutic area lead for Immunology &amp; Inflammation to drive and establish best practices to support Immunology &amp; Inflammation program continuous growth and Life Cycle Management (LCM) needs.</p><p></p><p><b>In this role, a typical day might include:</b></p><ul><li><p><span>Interacts with Medical Affairs functional area colleagues including but not limited to Medical Directors, HEOR, Publications, Medical Information, Scientific Communication and other functional area colleagues like Clinical Scientists, Statistical Programming, Data Management, Medical Writing, and others for evidence generation efforts and HTA support including external collaborators.</span></p></li><li><p><span>Develops individual protocols and statistical analysis plans and determines appropriate statistical methodology for data analysis.</span></p></li><li><p><span>Collaborates with Statistical Programming on the programming of tables, figures and listings to support decision making and for regulatory reporting.  </span></p></li><li><p><span>Evaluates appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.</span></p></li><li><p><span>Analyzes data and interprets results from clinical trials and of data from non-trial sources to facilitate program-level decision making.  </span></p></li><li><p><span>Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies.  Co-presents findings to management.  </span></p></li><li><p><span>To be involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians.  </span></p></li></ul><p></p><p><b>This role might be for you if you can/have:</b> ​ ​</p><ul><li><p><span>Strong interest and motivation in exploring existing clinical trial data for post-hoc analysis and innovative ideas investigations</span></p></li><li><p><span>Experience with designing clinical trials especially observational types of studies, and Bayesian methods, machine learning techniques and causal inference methods</span></p></li><li><p><span>Exposure to Dermatology/Respiratory study endpoints and analysis techniques </span></p></li><li><p><span>Strong communication skills to interpret, explain, and discuss results of complex statistical concepts and analyses to both technical and non-technical audiences.</span></p></li><li><p><span>Desire to present and share results with internal and external stakeholders and co-author publications, as well as present at statistical/medical congresses </span></p></li><li><p><span>Experience with providing scientific/statistical input into study design, formulating novel problem-solving methods and independently developing the statistical analysis plan to implement those solutions.</span></p></li><li><p><span>Experience of authoring Statistical Analysis Plans (SAP) and Protocols </span></p></li><li><p><span>Experience with innovative ways to generate tables, listings, and figures for external communication use in publications/presentations and for internal purposes.</span></p></li><li><p><span>Ability to translate and apply relevant innovative statistical methodology to everyday work.</span></p></li><li><p><span>Experience of educating and disseminating knowledge throughout the organization for areas within the expertise of medical affairs.</span></p></li></ul><p></p><p><b>To be considered for this opportunity, you must have the following:</b> ​ ​</p><ul><li><p><span>PhD or equivalent degree in statistics/biostatistics with &gt;4 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with &gt;9 years’ experience.  </span></p></li><li><p><span>Knowledge of drug life cycle management and strategies is preferred; knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies is a plus.</span></p></li><li><p><span>Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment.  </span></p></li><li><p><span>Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.</span></p></li><li><p><span>Be able to prioritize with multiple priorities and thrive in multitask type of environment</span></p></li><li><p><span>Solid knowledge of statistical analysis methodologies, experimental and clinical trial design</span></p></li><li><p><span>Ability to write code in statistical software (i.e. SAS, R, Python) is required. </span></p></li></ul><p></p><p>#GDBDMJobs</p><div><div><div><div><div><div><div><p></p><p>Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.<br />Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.<br /> </p><p></p><p>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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company&#39;s business.</p><p></p><p>For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.</p><p></p><p>Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.</p><p></p><p><span class="emphasis"><b><b>Salary Range (annually)</b></b></span></p></div></div></div></div></div></div></div>$150,500.00 - $245,500.00