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

Ascendis Pharma A/S; Palo Alto (CA); Hybrid; USD 200,000 - 215,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, dental, and vision plans

Life and AD&D insurance

Disability benefits

Professional Development

Health Saving Account

Job summary

Ascendis Pharma is seeking an Associate Director, Medical Affairs Statistical Sciences Biometrics to lead design, analysis and interpretation of post-approval trials, registries and real-world data to support publications and reimbursement strategies.

The role collaborates with R&D Biostatistics, Clinical Data Management and Statistical Programming to ensure statistical integrity, develop SAPs, and guide data-driven decision making. Hybrid Palo Alto, CA with competitive salary and benefits.

Qualifications

• PhD in Statistics, Biostatistics or Epidemiology with emphasis in statistics with at least 5 years in pharma/biotech, or MS with at least 8 years in industry.
• Knowledge in post-marketing study design, data analysis and interpretation and data-driven decision making.
• Experience in medical affairs statistical activities (RWE, reimbursement filing, data mining, external data).
• Hands-on programming using R and/or SAS.
• Familiarity with CDISC standards and regulatory guidelines for drug development.

Responsibilities

• Provides statistical support to Medical Affairs research programs, publications, data mining, and other evidence-generating activities.
• Collaborates with R&D Biostatistics, Clinical Data Management, and Statistical Programming for a broad range of activities.
• Ensures statistical integrity, adequacy and accuracy of analyses and results interpretation.
• Develops statistical analysis plans and data analysis methods; interprets findings.
• Leads development of complex technical solutions and contributes to ADaM standards.
• Reviews study protocols, CRFs, and internal project plans for proposed studies.
• Communicates clearly across multiple teams; applies statistical methods to real-world data.

Skills

Statistical analysis

Data mining

Real-world evidence

Cross-functional collaboration

Regulatory knowledge

Education

PhD in Statistics

PhD in Biostatistics

PhD in Epidemiology

Tools

R

SAS

Job description

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.

Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.

The Associate Director, Medical Affairs Statistical Sciences Biometrics provides technical and operational support for the design, implementation and interpretation of post approval clinical trials, programs, and disease registries. The incumbent works collaboratively with the medical affairs organization to develop and execute publication plans and to provide support to the global market access and health economic teams.

The Associate Director ensures will be working on biostatistics deliverables, including study design, data analysis, data mining, epidemiology-related analyses, use of clinical trial data to inform reimbursement strategy and HTA, real world evidence, quality of life data, and interpretation, reporting, and publication of results.

Main Tasks:

• Provides statistical support to Medical Affair research programs, publications, data mining, and other evidence generating activities

• Collaborates with counterparts in R&D Biostatistics, Clinical Data Management, Statistical Programming in providing support for a broad range of activities in the Medical Affairs
• Assures statistical integrity, adequacy and accuracy of statistical analysis and result interpretation
• Develops of statistical analysis plans, data analysis methods, and interpreting the resulting findings
• Contributes to the development of complex, technical solutions for projects
• Works with Biometrics counterparts on key statistical analyses, and contribute to developing ADaM standards, specifications and datasets as needed
• Contributes and reviews clinical study protocols, Case Report Forms (CRFs), and internal project plans for proposed studies
• Proficient programming and statistical skills through extensive on-the-job use
• Ability of Applying statistical methods/principles on real-world data in the Medical Affairs
• Design and execute statistical analysis plans (SAPs) for different phases of clinical studies, assuming a leadership role in creating strategy for statistical analyses
• Supports other departments for ad-hoc analyses, and provide technical consulting on internal and external projects
• Capable of communicate clearly and efficiently among multiple teams

• 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
• Knowledge in the principles and techniques 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 (e.g. RWE data generation, reimbursement filing, data mining, 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 required
• Familiarity with CDISC standards

Palo Alto, CA hybrid availability preferred but remote will be considered.

The estimated salary range for this position is $200-215k.Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a 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
• Unique offerings of 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

Ascendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.