Senior Manager, Statistical Programming: Job ID - 1646

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 Senior Manager, Statistical Programmer will be expected to provide timely support to the study team on all programming matters according to project strategies. This role is focused on supporting team. The incumbent should have hands-on skills and experiences in implementing and executing the programming and project standards to support in production or validation of CDISC SDTM, ADaM datasets, and Tables, Listings, Figures for clinical study reports, ISS, or ISE for assigned projects. Independently provide programming supports to statisticians in planned analysis, adhoc analysis, and demonstrate SAS programming proficiency. This position will be responsible for leading the programming aspect of a project for all programming deliverables from the single study through to regulatory approval. This position requires a comprehensive knowledge of CDISC standards, clinical trial study design, and electronic data submission requirements. Work collaboratively with study team to meet study deliverables and timeline for statistical data analysis and reporting.

Other responsibilities include but not limit to: develop and maintain standard programs, macros, templates, and libraries for use in clinical studies.

The position will be based in Palo Alto or may be remote.

Key Responsibilities

• Develop an expertise within a therapeutic area or standard tool for Statistical Programming function.
• Participate study team meeting to represent the Statistical Programming function to support or lead the study, focusing on data integrity, collaboration and on-time deliverables.
• Has good understanding to follow an analysis plan and prepare standard study SDTM, ADaM data specification and provide programming support for all of required deliverables
• Process clinical data required for statistical analysis. Develop SAS code or macros for preparing, processing and analyzing clinical data.
• Interact with members of project teams, statistician and data management personnel to perform statistical programming activities.
• Provide support in production or validation of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission.

Requirements

• A bachelor’s degree required in statistics, mathematics or equivalent with at least 10 years experience in pharmaceutical or bio-pharmaceutical industry or a master’s degree with at least 7 years in statistics or computer science is preferred.

• Demonstrated good verbal, written communication skills and interpersonal skills.

• 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.

Salary Range: $170-180K/year

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