Associate Director, Medical Affairs Statistical Sciences, Biometrics - ID: 1799

<p>Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.</p><p>Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.</p><p>Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.</p><p>Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.</p><p>The Associate Director, Medical Affairs Statistical Sciences Biometrics provides technical and operational support for the design, implementation and interpretation of post approval clinical trials, programs, and disease registries.&nbsp; The incumbent works collaboratively with the medical affairs organization to develop and execute publication plans and to provide support to the global market access and health economic teams. </p><p>The Associate Director ensures will be working on biostatistics deliverables, including study design, data analysis, data mining, epidemiology-related analyses, use of clinical trial data to inform reimbursement strategy and HTA, real world evidence, quality of life data, and interpretation, reporting, and publication of results. </p><p><br> <u><strong>Main Tasks:</strong></u></p><ul><li>Provides statistical support to Medical Affair research programs, publications, data mining, and other evidence generating activities </li><li>Collaborates with counterparts in R&amp;D Biostatistics, Clinical Data Management, Statistical Programming in providing support for a broad range of activities in the Medical Affairs</li><li>Assures statistical integrity, adequacy and accuracy of statistical analysis and result interpretation</li><li>Develops of statistical analysis plans, data analysis methods, and interpreting the resulting findings</li><li>Contributes to the development of complex, technical solutions for projects </li><li>Works with Biometrics counterparts on key statistical analyses, and contribute to developing ADaM standards, specifications and datasets as needed</li><li>Contributes and reviews clinical study protocols, Case Report Forms (CRFs), and internal project plans for proposed studies</li><li>Proficient programming and statistical skills through extensive on-the-job use</li><li>Ability of Applying statistical methods/principles on real-world data in the Medical Affairs </li><li>Design and execute statistical analysis plans (SAPs) for different phases of clinical studies, assuming a leadership role in creating strategy for statistical analyses</li><li>Supports other departments for ad-hoc analyses, and provide technical consulting on internal and external projects</li><li>Capable of communicate clearly and efficiently among multiple teams</li></ul> <ul><li>&nbsp;PhD in Statistics, Biostatistics or Epidemiology with emphasis in statistics or MS in Statistics, Biostatistics or Epidemiology with emphasis in statistics with at least 8 years of industry experience</li></ul><ul><li>Knowledge in the principles and techniques of post-marketing study design, data analysis and interpretation, and data-driven decision making. Familiarity with rare disease therapeutic areas is a plus</li><li>Experience designing and analyzing data from disease and/or product registry studies</li><li>Experience in Medical Affairs statistical activities (e.g. RWE data generation, reimbursement filing, data mining, use of external data including historical control data)</li><li>Hands-on statistical programming skills using R and/or SAS.</li><li>Familiarity with regulatory guidelines for drug development. Experience in NDA/BLA/MAA submission required</li><li>Familiarity with CDISC standards</li></ul><p></p><p>The estimated salary range for this position is $190-200k.&nbsp; Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location.&nbsp; This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.</p><p></p> <ul> <li>401(k) plan with company match</li> <li>Medical, dental, and vision plans</li> <li>Company-offered Life and Accidental Death &amp; Dismemberment (AD&amp;D) insurance</li> <li>Company-provided short and long-term disability benefits</li> <li>Unique offerings of Pet Insurance and Legal Insurance</li> <li>Employee Assistance Program</li> <li>Employee Discounts</li> <li>Professional Development</li> <li>Health Saving Account (HSA)</li> <li>Flexible Spending Accounts</li> <li>Various incentive compensation plans</li> <li>Accident, Critical Illness, and Hospital Indemnity Insurance&nbsp;&nbsp;</li> <li>Mental Health resources</li> <li>Paid leave benefits for new parents</li> </ul><p></p><p><strong>Ascendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.</strong></p><p><strong>A note to recruiters:</strong></p><p><strong>We do not allow external search party solicitation.&nbsp; Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.&nbsp; If this occurs your ownership of these candidates will not be acknowledged.</strong></p>