Associate Director - Medical Affairs Statistical Sciences, Biometrics

1w1 week ago

Ascendis Pharma

Palo Alto, US · Full-time · $190,000 – $200,000

About this role

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. We're advancing programs in Endocrinology Rare Disease and Oncology. Guided by core values of Patients, Science, and Passion, we use our TransCon® drug development platform.

The Associate Director, Medical Affairs Statistical Sciences Biometrics provides technical and operational support for post-approval clinical trials, programs, and disease registries. The incumbent works collaboratively with the medical affairs organization to develop publication plans. Also supports global market access and health economic teams.

Works on biostatistics deliverables including study design, data analysis, data mining, epidemiology-related analyses, real world evidence, and quality of life data. Handles interpretation, reporting, and publication of results. Contributes to use of clinical trial data for reimbursement strategy and HTA.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can make their mark. We offer a dynamic workplace for employees to grow and develop their skills. Pride ourselves on exceptional science, visionary leadership, and passionate colleagues.

Requirements

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
Knowledge in principles and techniques of post-marketing study design, data analysis and interpretation, and data-driven decision making
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
Familiarity with rare disease therapeutic areas is a plus

Responsibilities

Provides statistical support to Medical Affairs research programs, publications, data mining, and other evidence generating activities
Collaborates with counterparts in R&D Biostatistics, Clinical Data Management, Statistical Programming for Medical Affairs activities
Assures statistical integrity, adequacy and accuracy of statistical analysis and result interpretation
Develops statistical analysis plans, data analysis methods, and interprets resulting findings
Contributes to development of complex, technical solutions for projects
Works with Biometrics counterparts on key statistical analyses and developing ADaM standards, specifications and datasets
Reviews clinical study protocols, Case Report Forms (CRFs), and internal project plans
Designs and executes statistical analysis plans (SAPs) for different phases of clinical studies