Associate Director, Medical Affairs Statistical Sciences (Biometrics) - ID: 2069
Ascendis Pharma
Summary
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.
Job description
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
Requirements
- 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
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short & Long-Term Disability
- Pet Insurance
- Legal Insurance
- Employee Assistance Program
- Employee Discounts
- Professional Development
- Health Saving Account
- Flexible Spending Accounts
- Incentive Compensation Plans
- Accident & Critical Illness Insurance
- Mental Health Resources
- Paid Parental Leave
Company overview
Ascendis Pharma is a global biopharmaceutical company founded in 2007 and headquartered in Hellerup, Denmark, with additional facilities across Europe and the United States. The company is publicly traded on Nasdaq under the symbol ASND. Ascendis Pharma specializes in applying its innovative TransCon technology platform to develop novel therapies that address unmet medical needs in endocrinology rare diseases and oncology. The company's core values of Patients, Science, and Passion guide its mission to create potentially best-in-class therapies. Ascendis has two marketed products: SKYTROFA (lonapegsomatropin-tcgd) for pediatric growth hormone deficiency and YORVIPATH (palopegteriparatide) for adult hypoparathyroidism. The company's pipeline includes TransCon CNP for achondroplasia and oncology candidates like TransCon TLR7/8 Agonist and TransCon IL-2 β/γ. With approximately 1,017 employees globally as of December 2024, Ascendis operates through a combination of direct commercialization in key markets and strategic partnerships in regions like Greater China and Japan through VISEN Pharmaceuticals and Teijin Limited, respectively.