Are you passionate about leading and supporting statistical programming activities to support drug development?
Learn more about the general tasks related to this opportunity below, as well as required skills.
Do you have experience within SAS and CDISC standards, project and resource management?
If so, you have the chance to join Ascendis Pharma as our new Associate Director, Statistical Programming.
Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day.
As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.
The Role
As our new Associate Director, Statistical Programming, you will manage internal and external resources to lead, or support assigned project statistical programming activities.
You will provide programming support to statisticians in production of summary tables, data listings and graphs required for clinical trials, and CDISC datasets for regulatory submission.
This position requires a comprehensive knowledge of SAS and CDISC standards, project and resource management, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process.
The Associate Director may provide statistical programming expertise on departmental and cross-functional process improvement initiatives.
Other responsibilities include but are not limited to managing projects with partner and functional service providers (FSP).
The position will be based in Palo Alto, CA and may be remote; it will report directly to the Sr. Director, Statistical Programming located in Palo Alto.
You will be responsible for :
- Representing the Statistical Programming team as study lead, focusing on data integrity, collaboration, and on-time deliverables.
- Managing and providing oversight of Statistical Programming FTEs, contractors, and CROs.
- Processing clinical data required for statistical analysis. Develop SAS code and table templates for preparing, processing, and analyzing clinical data.
- Interacting with members of project teams, statisticians, and data management personnel to establish project timelines and perform statistical analyses.
- Providing support in production of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission.
- Managing assigned project programming activities to ensure timely delivery of tables and data listings. Provide guidance and QC / QA standards to ensure quality of deliverables.
You hold a relevant academic degree either as a Bachelor of Science with 12 years of pharma industry experience as a programmer or a Master of Science with 10 years of pharma industry experience as a programmer.
You are proficient in English at a professional level, both written and spoken.
Furthermore, you have :
- At least 3 years of experience in managing FTEs, FSPs, and CRO.
- A minimum of 2 years experience working with CRO.
- Prior experience in participation of NDA / BLA submissions.
As a person, you are :
- Demonstrated leadership and excellent interpersonal skills.
- Exceptional communication skills, with an ability to discuss programming topics with individuals ranging in programming understanding.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
Travel : 5 - 20 days per year
New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
Estimated salary : 180-210K / year
Benefits
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance
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