Associate Director, Medical Affairs Statistical Sciences, Biometrics - ID: 1799 job opportunity at Ascendis Pharma.

Home Jobs In United States Of America Tag: Medical Affairs Statistical Sciences, Biometrics - ID: 1799 Associate Director, Medical Affairs Statistical Sciences, Biometrics - ID: 1799 position at Ascendis Pharma


Date2025-11-11T00:04:54.017Z bot
Ascendis Pharma Associate Director, Medical Affairs Statistical Sciences, Biometrics - ID: 1799
Experience: 5-years
Pattern: Full-time
Country:
apply Apply Now
Salary:
Status:

Medical Affairs Statistical Sciences, Biometrics - ID: 1799

Copy Link Report
degreeAssociate
loacation Palo Alto, United States Of America
loacation Palo Alto....United States Of America

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. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. 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. 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. 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.  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. 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. Main Tasks: Provides statistical support to Medical Affair research programs, publications, data mining, and other evidence generating activities Collaborates with counterparts in R&D Biostatistics, Clinical Data Management, Statistical Programming in providing support for a broad range of activities in the Medical Affairs Assures statistical integrity, adequacy and accuracy of statistical analysis and result interpretation Develops of statistical analysis plans, data analysis methods, and interpreting the resulting findings Contributes to the development of complex, technical solutions for projects Works with Biometrics counterparts on key statistical analyses, and contribute to developing ADaM standards, specifications and datasets as needed Contributes and reviews clinical study protocols, Case Report Forms (CRFs), and internal project plans for proposed studies Proficient programming and statistical skills through extensive on-the-job use Ability of Applying statistical methods/principles on real-world data in the Medical Affairs Design and execute statistical analysis plans (SAPs) for different phases of clinical studies, assuming a leadership role in creating strategy for statistical analyses Supports other departments for ad-hoc analyses, and provide technical consulting on internal and external projects Capable of communicate clearly and efficiently among multiple teams  PhD in Statistics, Biostatistics or Epidemiology with emphasis in statistics with at least 5 years of pharma / biotech industry experience, or MS in Statistics, Biostatistics or Epidemiology with emphasis in statistics with at least 8 years of industry experience 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 Experience designing and analyzing data from disease and/or product registry studies Experience in Medical Affairs statistical activities (e.g. RWE data generation, reimbursement filing, data mining, use of external data including historical control data) Hands-on statistical programming skills using R and/or SAS. Familiarity with regulatory guidelines for drug development. Experience in NDA/BLA/MAA submission required Familiarity with CDISC standards The estimated salary range for this position is $190-200k.  Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location.  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.

Other Ai Matches

ServiceNow Platform Architect Applicants are expected to have a solid experience in handling Job related tasks
Manager, Global Publication Planning - Job ID: 1844 Applicants are expected to have a solid experience in handling Global Publication Planning - Job ID: 1844 related tasks
Field Reimbursement Manager (South Florida/Puerto Rico) - Job ID: FRMSFPR Applicants are expected to have a solid experience in handling Job related tasks
Piccoline/Piccolo til kontor i Hellerup Applicants are expected to have a solid experience in handling Job related tasks
Senior Manager, Regulatory Project Manager - Job ID: 1820 Applicants are expected to have a solid experience in handling Regulatory Project Manager - Job ID: 1820 related tasks
Associate Director, US Medical Training - Job ID: 1691 Applicants are expected to have a solid experience in handling US Medical Training - Job ID: 1691 related tasks
Payroll Specialist Applicants are expected to have a solid experience in handling Job related tasks
ICSR Management Lead-Contractor - Job ID: ICSRC Applicants are expected to have a solid experience in handling Job related tasks
Associate Medical Director, Endocrine Medical Sciences - Job ID: 1795 Applicants are expected to have a solid experience in handling Endocrine Medical Sciences - Job ID: 1795 related tasks
Accountant, Global Finance Operations P2P Applicants are expected to have a solid experience in handling Global Finance Operations P2P related tasks
Assistant General Counsel, US Commercial & Medical - Job ID: 1838 Applicants are expected to have a solid experience in handling US Commercial & Medical - Job ID: 1838 related tasks
Marketing - Summer Intern Applicants are expected to have a solid experience in handling Job related tasks
Public Affairs - Summer Intern Applicants are expected to have a solid experience in handling Job related tasks
Clinical Disclosure Specialist Applicants are expected to have a solid experience in handling Job related tasks
Senior Clinical Scientist - Job ID: 1845 Applicants are expected to have a solid experience in handling Job related tasks
IT Product Owner - Digital Learning and Enablement Applicants are expected to have a solid experience in handling Job related tasks
Senior Manager, Global Regulatory Operations Applicants are expected to have a solid experience in handling Global Regulatory Operations related tasks
Safety Data Analysis and Reporting Lead, Global Patient Safety Medical Science Applicants are expected to have a solid experience in handling Global Patient Safety Medical Science related tasks
IT Infrastructure Architect Applicants are expected to have a solid experience in handling Job related tasks
Head of US Training - Job ID: 1860 Applicants are expected to have a solid experience in handling Job related tasks
Clinical Disclosure Specialist Applicants are expected to have a solid experience in handling Job related tasks
Professional Procurement & Logistics (f/m/d) Applicants are expected to have a solid experience in handling Job related tasks
Key Account Manager - Italy Applicants are expected to have a solid experience in handling Job related tasks