Senior Manager, Statistical Programming

3 weeks ago

Palo Alto, United States Ascendis Pharma Full time

Senior Manager, Statistical ProgrammingAscendis 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 Programming, will be expected to provide timely and strategic programming support to clinical study teams in alignment with project goals. This role combines hands-on programming responsibilities with leadership in study execution and tool development.The successful candidate will serve as the Statistical Programming Lead for one or more clinical trials, taking responsibility for all programming deliverables from study start through regulatory submission. In addition, this person will support the development and maintenance of departmental programming tools, such as standard macros and specification templates of SDTM and ADaM used across clinical studies.This position requires expertise in CDISC standards (SDTM, ADaM), strong communication and leadership skills, and a deep understanding of clinical trial data and analysis workflows.This position is based in Palo Alto, CA or may be remote.Key ResponsibilitiesServe as the Statistical Programming Lead for clinical trials, overseeing all programming deliverables from study start to 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, following 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 cross-functional teams including Biostatistics, Data Management, and Medical Writing to ensure high-quality deliverables.Ensure programming activities meet project timelines and quality expectations, following internal SOPs and industry best practices.

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