Associate Director, Medical Affairs, Statistical Sciences

🔥 1 minute ago

🏄 California – Remote

🏄 California – Remote

💵 $200k - $215k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 1%

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Ascendis Pharma

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2006

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Ascendis Pharma is a pharmaceutical company focused on developing innovative therapies to address unmet medical needs, particularly in the areas of endocrinology and oncology. The company utilizes its proprietary TransCon technology platform to develop best-in-class therapies, with a strong emphasis on patient care, scientific innovation, and sustainability. Ascendis Pharma's pipeline includes TransCon PTH and TransCon CNP for endocrinology rare diseases, as well as oncology candidates such as TransCon TLR7/8 Agonist. Committed to making a meaningful difference in the lives of patients, caregivers, physicians, and employees, Ascendis Pharma is guided by its core values and driven by its mission to impact patient lives worldwide.

📋 Description

• 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

• 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

• 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