AD, Medical Affairs Statistical Sciences Programming, Biometrics - Job ID: 1565
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.
Associate Director, Medical Affairs Statistical Sciences Programming will be responsible for statistical programming deliverables and will play a key role in support of real-world research projects and lead the programming activities in post-market approval projects.
This position requires a comprehensive knowledge of SAS and CDISC standards, project and resource management, understanding the pharmaceutical drug development process and use of clinical trial data to inform reimbursement strategy and market access submissions.The Associate Director may provide statistical programming expertise on departmental and cross-functional process improvement initiatives. Other responsibilities include but not limit to: managing projects with partner and functional service providers.
The preferred location for this position is in our office in Palo Alto, California. Remote work will be considered for the right applicant.
Main Tasks- Provides statistical programming support to Medical Affairs research programs, publications, processing and applying real-world data, 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 Medical Affairs programming activities.
- Ensures efficiency, timeliness and quality of deliverables of statistical analysis outputs.
- Conduct statistical programming of clinical trial and real-world data using SAS and R Software.
- Develops and QC statistical outputs.
- Works with Biometrics counterparts on key statistical analyses, and contribute to developing process, ADaM standards, specifications and datasets as needed.
- Supports other departments for ad-hoc analyses and provide technical consulting on internal and external projects.
- Bachelor's degree in relevant field with 8 years of pharma experience is required; Masters degree highly preferred.
- Knowledge of applying statistics and epidemiology on RWD. Familiarity with rare disease therapeutic and/or endocrinology areas is a plus.
- Experienced in analyzing data from rare 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, and real-world data).
- Proficient in SAS with the ability to independently write code and provide guidance to other programmers for various activities and experience with developing code in R language.
- Familiarity with regulatory guidelines for drug development. Experience in NDA/BLA/MAA submission is plus.
- Proficient with CDISC standards.
- Minimal travel for business needs as required.
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.
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
- 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