Associate Director, Statistical Programming
Company: Ascendis Pharma
Location: Palo Alto
Posted on: January 25, 2023
The Associate Director, Statistical Programming, will manage
internal and external resources to lead or support assigned project
statistical programming activities. Provide programming supports 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 not limit to: managing projects
with partner and functional service providers (FSP). The position
will be based in Palo Alto and will report directly to the Sr.
Director, Statistical Programming. Key Responsibilities
- Represent the Statistical Programming team as study lead,
focusing on data integrity, collaboration and on-time
- Manage and provide oversight of Statistical Programming FTEs,
contractors, and CROs.
- Process clinical data required for statistical analysis.
Develop SAS code and table templates for preparing, processing and
analyzing clinical data.
- Interact with members of project teams, statistician and data
management personnel to establish project timelines and perform
- Provide support in production of summary tables, data listings
and graphs required for trial report and clinical development, and
CDISC data sets for regulatory submission.
- Manage assigned project programming activities to ensure timely
delivery of tables and data listings. Provide guidance and QC/QA
standards to ensure quality of deliverables.
- A bachelor's degree required in statistics, mathematics or
equivalent with at least 12 years experience in pharmaceutical or
bio-pharmaceutical industry or a master's degree with at least 10
years in statistics or computer science is preferred.
- At least 3 years of experience in managing FTEs, FSPs, and
- A minimum of 2 years experience working with CRO.
- Prior experience in participation of NDA/BLA submissions.
- Demonstrated leadership and excellent interpersonal
- Exceptional communication skills, with an ability to discuss
programming topics with individuals ranging in programming
- 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.
- 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
- Medical insurance
- Vision insurance
- Dental insurance
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance
Keywords: Ascendis Pharma, Palo Alto , Associate Director, Statistical Programming, Executive , Palo Alto, California
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