Associate Director, Medical Affairs Statistical Sciences, Biometrics - ID: 1799
Ascendis Pharma, Palo Alto, CA, United States
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 will deliver 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 Affairs research programs, publications, data mining, and other evidence generating activities
Collaborates with counterparts in R&D Biostatistics, Clinical Data Management, Statistical Programming to provide support for a broad range of activities in Medical Affairs
Assures statistical integrity, adequacy and accuracy of statistical analysis and result interpretation
Develops statistical analysis plans, data analysis methods, and interprets the resulting findings
Contributes to the development of complex, technical solutions for projects
Works with Biometrics counterparts on key statistical analyses, and contributes 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
Applies statistical methods/principles on real-world data in Medical Affairs
Designs and executes 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, providing technical consulting on internal and external projects
Communicates clearly and efficiently among multiple teams
Qualifications
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; 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 such as experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or incentive compensation plan, discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.
Benefits
401(k) plan with company match
Medical, dental, and vision plans
Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Pet Insurance and Legal Insurance
Employee Assistance Program
Employee Discounts
Professional Development
Health Savings Account (HSA)
Flexible Spending Accounts
Various incentive compensation plans
Accident, Critical Illness, and Hospital Indemnity Insurance
Mental Health resourcesPaid leave benefits for new parents
Ascendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr
Main Tasks
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 to provide support for a broad range of activities in Medical Affairs
Assures statistical integrity, adequacy and accuracy of statistical analysis and result interpretation
Develops statistical analysis plans, data analysis methods, and interprets the resulting findings
Contributes to the development of complex, technical solutions for projects
Works with Biometrics counterparts on key statistical analyses, and contributes 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
Applies statistical methods/principles on real-world data in Medical Affairs
Designs and executes 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, providing technical consulting on internal and external projects
Communicates clearly and efficiently among multiple teams
Qualifications
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; 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 such as experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or incentive compensation plan, discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.
Benefits
401(k) plan with company match
Medical, dental, and vision plans
Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Pet Insurance and Legal Insurance
Employee Assistance Program
Employee Discounts
Professional Development
Health Savings Account (HSA)
Flexible Spending Accounts
Various incentive compensation plans
Accident, Critical Illness, and Hospital Indemnity Insurance
Mental Health resourcesPaid leave benefits for new parents
Ascendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr