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Ascendis Pharma

Biopharmaceutical company developing long-acting prodrugs

Associate Director, Medical Affairs Statistical Sciences (Biometrics)

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-time$200k - $215k

About the Job

Requirements

  • A 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 those fields 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.
  • Experience designing and analyzing data from disease and/or product registry studies.
  • Experience in Medical Affairs statistical activities, such as real-world evidence data 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 and experience in NDA/BLA/MAA submissions.
  • Familiarity with CDISC standards.

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 a broad range of Medical Affairs activities.
  • Ensure the statistical integrity, adequacy, and accuracy of statistical analyses and interpretation of results.
  • Develop statistical analysis plans and data-analysis methods, and interpret resulting findings.
  • Contribute to the development of complex technical solutions for projects.
  • Work with Biometrics counterparts on key statistical analyses and contribute to developing 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.
  • Design and execute statistical analysis plans for different phases of clinical studies, assuming a leadership role in creating strategy for statistical analyses.
  • Support other departments with ad hoc analyses and provide technical consulting on internal and external projects.

Desired Qualifications

  • Familiarity with rare disease therapeutic areas.

About the Company

Ascendis Pharma

Biopharmaceutical company developing long-acting prodrugs

Ascendis Pharma uses its TransCon technology to create long-acting prodrugs for rare endocrine diseases, with expansions into oncology and ophthalmology. The platform temporarily attaches an unmodified drug to an inert carrier and releases the active drug in a predictable, sustained way after injection, reducing how often patients must dosing. It differentiates itself through a proprietary delivery system and a track record that includes marketed therapies like SKYTROFA for pediatric growth hormone deficiency and YORVIPATH for hypoparathyroidism, along with collaborations such as a Novo Nordisk deal. The company aims to improve patient outcomes by enabling easier, less frequent dosing while expanding its pipeline across rare endocrine diseases, cancer, and eye diseases.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Gentofte Municipality, Denmark
Founded
2007

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