Associate Director, Medical Affairs, Statistical Sciences

Ascendis Pharma

. Provide technical and operational support for the design, implementation and interpretation of post-approval clinical trials, programs, and disease registries .

Posted 10/23/2026full-timeRemote • California • United StatesSenior💰 $200,000 - $215,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in statistical analysis and biostatistics, with a strong focus on clinical trial design, data interpretation, and real-world evidence generation. Proven ability to collaborate with cross-functional teams and ensure statistical integrity in pharmaceutical and biotech settings.

Highest-signal resume keywords

PhD In Statistics, Biostatistics Or EpidemiologyStatistical Programming Using R And/or SASExperience In NDA/BLA/MAA SubmissionKnowledge Of Post-Marketing Study DesignFamiliarity With CDISC Standards

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

BiostatisticsData AnalysisEpidemiologyStatistical Analysis PlansData MiningQuality-Of-Life Data InterpretationReimbursement And HTA AnalysesStatistical IntegrityStatistical ConsultingClinical Study Protocols

Soft Skills

CollaborationTechnical ConsultingCommunication

Industry Keywords

Pharma Industry ExperienceBiotech Industry ExperienceMedical AffairsReal-World EvidenceRegulatory GuidelinesRare Disease Therapeutic AreasDisease RegistriesPost-Approval Clinical TrialsEvidence-Generating ActivitiesExternal Data

About the role

Key responsibilities & impact

Provide technical and operational support for the design, implementation and interpretation of post-approval clinical trials, programs, and disease registries
Collaborate with Medical Affairs to develop and execute publication plans
Support global market access and health economic teams
Deliver biostatistics work including study design, data analysis, data mining, epidemiology-related analyses, reimbursement and HTA analyses, real-world evidence, and quality-of-life data interpretation
Provide statistical support to Medical Affairs research programs, publications, data mining, and evidence-generating activities
Collaborate with R&D Biostatistics, Clinical Data Management, and Statistical Programming counterparts
Ensure statistical integrity, adequacy, and accuracy of analyses and result interpretation
Develop statistical analysis plans and data analysis methods and interpret findings
Contribute to complex technical solutions for projects
Work with Biometrics counterparts on statistical analyses and ADaM standards, specifications, and datasets
Contribute to and review clinical study protocols, Case Report Forms, and internal project plans
Design and execute SAPs for different phases of clinical studies and lead statistical analysis strategy
Support ad-hoc analyses and provide technical consulting on internal and external projects

Requirements

What you’ll need

PhD in Statistics, Biostatistics or Epidemiology with emphasis in statistics and at least 5 years of pharma / biotech industry experience, or MS in Statistics, Biostatistics or Epidemiology with 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
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, including RWE data generation, reimbursement filing, data mining, and use of external 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

Benefits

Comp & perks

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 Saving 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
Discretionary annual bonus or incentive compensation plan eligibility
Discretionary stock-based long-term incentives
Paid time off
Comprehensive benefits package