Senior Manager, Statistical Programming - Job ID: 1646

Ascendis Pharma•Palo Alto, CA

17h•$170,000 - $180,000

About The Position

Ascendis Pharma is a global biopharmaceutical company advancing programs in Endocrinology Rare Disease and Oncology. Guided by its values of Patients, Science, and Passion, the company uses its TransCon® drug development platform to develop potentially best-in-class therapies for unmet medical needs. Its culture emphasizes exceptional science, visionary leadership, and opportunities for employees to grow and develop. The Senior Manager, Statistical Programming, provides timely and strategic programming support to clinical study teams, combining hands-on programming with leadership in study execution and tool development. The role serves as Statistical Programming Lead for one or more clinical trials and is responsible for programming deliverables from study start through regulatory submission. It also supports the development and maintenance of departmental programming tools, including standard macros and SDTM and ADaM specification templates. The position is based in Palo Alto, California, or may be remote.

Requirements

Bachelor’s degree in Statistics, Mathematics, Computer Science, or a related field and at least 10 years of programming experience in the pharmaceutical or biotech industry; alternatively, a Master’s degree and at least 7 years of relevant experience.
Proven experience as a lead programmer for clinical trials and complex technical projects.
Excellent knowledge of CDISC standards, including SDTM and ADaM.
Understanding of the clinical drug development process and regulatory requirements.
Proficiency in SAS programming, including developing and validating reusable macros.
Strong verbal and written communication skills and the ability to collaborate effectively across functions.
Self-motivated and detail-oriented, with the ability to manage multiple tasks and adapt to shifting priorities under tight deadlines.

Nice To Haves

Familiarity with other programming languages or tools, such as R, Python, Git, or VB.
Experience contributing to departmental tools, such as macro libraries, specification templates, or automation tools.

Responsibilities

Serve as the Statistical Programming Lead for clinical trials, overseeing programming deliverables from study start through submission.
Represent Statistical Programming in cross-functional study team meetings and contribute to project planning and timelines.
Develop, validate, and maintain SDTM and ADaM datasets according to CDISC standards and study specifications.
Generate or validate tables, listings, and figures (TLFs) for clinical study reports, ISS/ISE, and regulatory submissions.
Support statisticians with planned and ad hoc analyses.
Develop and maintain reusable macros, templates, and specification tools to support consistent and efficient programming practices across studies.
Collaborate with Biostatistics, Data Management, Medical Writing, and other cross-functional teams to ensure high-quality deliverables.
Ensure programming activities meet project timelines and quality expectations while following internal SOPs and industry best practices.