Associate Director, Medical Affairs Statistical Sciences, Biometrics - ID: at Ascendis Pharma

Palo Alto, California, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Feb, 26

Salary

200000.0

Posted On

11 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Statistical Support, Data Analysis, Biostatistics, Epidemiology, Statistical Programming, Clinical Trials, Real World Evidence, Data Mining, Regulatory Guidelines, NDA Submission, CDISC Standards, Publication Plans, Health Economics, Study Design, Technical Consulting, Collaboration

Industry

Biotechnology Research

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 The estimated salary range for this position is $190-200k. 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. A note to recruiters: We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Responsibilities

The Associate Director provides technical and operational support for the design, implementation, and interpretation of post-approval clinical trials and disease registries. They work collaboratively with the medical affairs organization to develop publication plans and support global market access teams.