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Salary: USD 170,000 - 180,000 / annual
Ascendis Pharma, a global biopharmaceutical company advancing programs in Endocrinology Rare Disease and Oncology, seeks a Senior Manager of Statistical Programming to lead clinical trial programming efforts and drive departmental tool development.
In this hybrid role based in Palo Alto, CA, you will serve as the Statistical Programming Lead for one or more clinical trials, owning all programming deliverables from study initiation through regulatory submission. You will represent Statistical Programming in cross-functional study team meetings, contribute to project planning and timelines, and ensure programming activities meet quality expectations and internal SOPs.
Key responsibilities include:
- Leading all statistical programming deliverables for clinical trials, including SDTM and ADaM dataset development and validation following CDISC standards
- Generating and validating tables, listings, and figures (TLFs) for clinical study reports, ISS/ISE, and regulatory submissions
- Supporting statisticians with planned and ad hoc analyses
- Developing and maintaining reusable SAS macros, templates, and specification tools to enable consistent and efficient programming practices across studies
- Collaborating with Biostatistics, Data Management, and Medical Writing teams to ensure high-quality deliverables
- Managing multiple tasks and adapting to shifting priorities under tight deadlines
You will combine hands-on programming expertise with leadership in study execution and tool development, serving as a technical authority and mentor within the statistical programming function.
REQUIREMENTS:
- Bachelor's degree in Statistics, Mathematics, Computer Science, or related field with at least 10 years of pharmaceutical/biotech programming experience; OR Master's degree with 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 (SDTM and ADaM)
- Understanding of clinical drug development processes and regulatory requirements
- Proficiency in SAS programming, including ability to develop and validate reusable macros
- Familiarity with R, Python, Git, or VB is a plus
- Experience contributing to departmental tools (macro libraries, specification templates, automation tools) preferred
- Strong verbal and written communication skills with ability to collaborate across functions
- Self-motivated, detail-oriented, and able to manage multiple priorities under tight deadlines
