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

Ascendis Pharma•Palo Alto, CA

About The Position

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.

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 the 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. Experience in NDA/BLA/MAA submission required
Familiarity with CDISC standards

Nice To Haves

Familiarity with rare disease therapeutic areas is a plus

Responsibilities

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