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Senior Manager, Statistical Programming- Job ID: 1471

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Canada, California (USA), United States

Offer summary

Qualifications:

Bachelor's degree with 10 years experience in pharma programming or Master's with 8 years, At least 3 years managing FTEs and CROs, Experience with NDA/BLA submissions, Proficient in SAS and CDISC standards, Professional English proficiency required.

Key responsabilities:

Manage internal and external programming resources for clinical trials
Provide oversight of statistical programming FTEs, contractors, and CROs
Develop SAS code and templates for clinical data analysis
Ensure timely delivery of tables and datasets for regulatory submission
Lead projects while focusing on data integrity and collaboration

Ascendis Pharma SME https://www.ascendispharma.com/

501 - 1000 Employees

See more Ascendis Pharma offers

Job description

Are you passionate about leading and supporting statistical programming activities to support drug development?

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 Senior Manager, 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.

As our new Senior Manager, 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 Senior Manager 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 may be remote it will report directly to the Director, Statistical Programming – Oncology.

You will be responsible for:

Representing the Statistical Programming team as study lead, focusing on data integrity, collaboration, and on-time deliverables. This work supports our oncology team.
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, statistician, 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.

Requirements

You hold a relevant academic degree either as a Bachelor of science with 10 years of pharma industry experience as a programmer or a Master of Science with 8 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.

Preferred:

Oncology experience is preferred or a plus

Travel: 5 - 20 days per year

Estimated salary: 175-185K/year DOE

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