Associate Director, Medical Affairs Statistical Sciences (Biometrics) - ID: 2069

Ascendis Pharma

2d•$200,000 - $215,000•Hybrid

About The Position

The Associate Director, Medical Affairs Statistical Sciences Biometrics provides technical and operational statistical support for the design, implementation, and interpretation of post-approval clinical trials, programs, and disease registries. The role works collaboratively with Medical Affairs to develop and execute publication plans and supports global market access and health economics teams. The position delivers biostatistics work across study design, data analysis and mining, epidemiology-related analyses, real-world evidence, quality-of-life data, use of clinical trial data to inform reimbursement strategy and health technology assessment, and interpretation, reporting, and publication of results. It also supports statistical strategy and analysis across clinical study phases, contributes to standards and datasets, and provides consulting and ad hoc analysis support to other departments.

Requirements

PhD in Statistics, Biostatistics, or Epidemiology with emphasis in statistics and at least 5 years of pharmaceutical or biotechnology industry experience, or an MS in one of these fields with emphasis in statistics and at least 8 years of industry experience.
Knowledge of 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, 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.
Familiarity with regulatory guidelines for drug development.
Experience in NDA/BLA/MAA submission.
Familiarity with CDISC standards.

Nice To Haves

Familiarity with rare disease therapeutic areas.

Responsibilities

Provide statistical support for 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 a broad range of Medical Affairs activities.
Assure the statistical integrity, adequacy, and accuracy of analyses and interpretation of results.
Develop statistical analysis plans and data analysis methods, and interpret resulting findings.
Contribute to developing 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 (CRFs), and internal project plans for proposed studies.
Apply statistical methods and principles to real-world data in Medical Affairs.
Design and execute statistical analysis plans for different phases of clinical studies, taking a leadership role in statistical analysis strategy.
Support other departments with ad hoc analyses and provide technical consulting on internal and external projects.
Communicate clearly and efficiently among multiple teams.

Benefits

Discretionary annual bonus or incentive compensation plan, with eligibility varying by role and position level.
Discretionary stock-based long-term incentives.
Paid time off.
Comprehensive benefits package.
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 resources.
Paid leave benefits for new parents.