Associate Director, Medical Affairs Statistical Sciences (Biometrics)
New
A
Ascendis PharmaBiopharmaceuticals
Workable workplace: remote; Workable locations: United States; remote will be considered.Full-TimeDirector
SalaryThe estimated salary range for this position is $200-215k.
Apply NowOpens the employer's application page
Job Details
- Experience
- 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
- Required Skills
- R
Requirements
- PhD in Statistics, Biostatistics, or Epidemiology with an emphasis in statistics, and at least 5 years of pharma/biotech industry experience; or an MS in one of these fields with an emphasis in statistics and at least 8 years of industry experience.
- Knowledge 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, such as real-world evidence generation, reimbursement filing, data mining, and use of external data including historical control data.
- Hands-on statistical programming skills using R and/or SAS.
- Experience with NDA/BLA/MAA submissions.
- Familiarity with regulatory guidelines for drug development.
- Familiarity with CDISC standards.
- Ability to apply statistical methods and principles to real-world data in Medical Affairs.
- Clear and efficient communication among multiple teams.
Responsibilities
- Provide statistical support to Medical Affairs research programs, publications, data mining, and other evidence-generating activities.
- Collaborate with R&D Biostatistics, Clinical Data Management, and Statistical Programming counterparts to support Medical Affairs activities.
- Ensure the statistical integrity, adequacy, and accuracy of analyses and result interpretation.
- Develop statistical analysis plans and data analysis methods, and interpret the resulting findings.
- Contribute to complex technical solutions for projects.
- Work with Biometrics counterparts on key statistical analyses and contribute to ADaM standards, specifications, and datasets as needed.
- Contribute to and review clinical study protocols, Case Report Forms, and internal project plans.
- Design and execute statistical analysis plans for clinical study phases and lead statistical analysis strategy.
- Support other departments with ad hoc analyses and provide technical consulting on internal and external projects.
- Support study design, data analysis, data mining, epidemiology-related analyses, real-world evidence, reimbursement strategy, and HTA.
View Full Description & ApplyYou'll be redirected to the employer's site
