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Salary: USD 200,000 - 215,000 / annual
Ascendis Pharma, a global biopharmaceutical company advancing programs in Endocrinology Rare Disease and Oncology, is seeking an Associate Director of Medical Affairs Statistical Sciences (Biometrics). This role provides technical and operational leadership for the design, implementation, and interpretation of post-approval clinical trials, disease registries, and evidence-generation programs.
You will lead biostatistics deliverables including study design, data analysis, data mining, epidemiology-related analyses, and the application of clinical trial data to inform reimbursement strategy and health technology assessment (HTA). You'll work collaboratively across Medical Affairs, R&D Biostatistics, Clinical Data Management, and Statistical Programming to develop and execute publication plans, support global market access initiatives, and generate real-world evidence.
Key responsibilities include:
- Providing statistical support to Medical Affairs research programs, publications, and evidence-generating activities
- Developing statistical analysis plans (SAPs), data analysis methods, and interpreting findings with a leadership role in creating strategy for statistical analyses
- Assuring statistical integrity, adequacy, and accuracy of statistical analysis and result interpretation
- Contributing to complex technical solutions and developing ADaM standards, specifications, and datasets
- Reviewing clinical study protocols, Case Report Forms (CRFs), and internal project plans
- Designing and analyzing data from disease and product registry studies
- Applying statistical methods to real-world data in Medical Affairs contexts
- Supporting ad-hoc analyses and providing technical consulting on internal and external projects
- Communicating clearly and efficiently across multiple teams
Requirements:
- PhD in Statistics, Biostatistics, or Epidemiology (with emphasis in statistics) and at least 5 years of pharma/biotech industry experience; OR MS in Statistics, Biostatistics, or Epidemiology (with emphasis in statistics) and at least 8 years of industry experience
- Knowledge of post-marketing study design, data analysis, interpretation, and data-driven decision making; familiarity with rare disease therapeutic areas is a plus
- Hands-on experience designing and analyzing data from disease and/or product registry studies
- Experience in Medical Affairs statistical activities (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; NDA/BLA/MAA submission experience required
- Familiarity with CDISC standards
