Statistical Programming Lead – Clinical Trials (SDTM/ADaM)

Ascendis Pharma A/S; Palo Alto (CA); Hybrid; USD 170,000 - 180,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, dental, and vision plans

AD&D insurance

Disability benefits

Pet Insurance

Legal Insurance

Employee Assistance Program

Employee Discounts

Professional Development

Health Saving Account (HSA)

Flexible Spending Accounts

Incentive compensation plans

Accident, Critical Illness, and Hotel?

Job summary

Ascendis Pharma is seeking a Senior Manager, Statistical Programming to lead programming deliverables for clinical trials, leveraging CDISC SDTM/ADaM and SAS expertise. Based in Palo Alto, CA, with option for remote work, the role combines hands-on programming with leadership in study execution and tool development.

You will guide SDTM/ADaM datasets, generate TLFs for submissions, mentor teams, and help build reusable macros and templates.

Qualifications

• Bachelor’s or Master’s degree with substantial pharm/biotech programming 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 reusable macros.
• Familiarity with R, Python, Git, VB is a plus.
• Experience contributing to departmental tools like macro libraries and automation tools.
• Strong communication and cross-functional collaboration skills.
• Self-motivated with strong attention to detail and ability to manage multiple tasks.

Responsibilities

• Serve 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 and regulatory submissions.
• Support statisticians with planned and ad hoc analyses.
• Develop and maintain reusable macros, templates, and specification tools to support consistent programming practices.
• Collaborate with Biostatistics, Data Management, and Medical Writing to ensure high-quality deliverables.
• Ensure programming activities meet timelines and quality standards per SOPs.

Skills

SAS programming

CDISC SDTM/ADaM

Lead programmer

Regulatory submissions

Biotech/pharma domain

R

Python

Git

VB

Team leadership

Education

Bachelor’s degree in Statistics, Mathematics, Computer Science

Master’s degree in relevant field

Tools

SAS

R

Python

Git

VB

Job description

Ascendis Pharma is seeking a Senior Manager, Statistical Programming to lead programming deliverables for clinical trials, leveraging CDISC SDTM/ADaM and SAS expertise. Based in Palo Alto, CA, with option for remote work, the role combines hands-on programming with leadership in study execution and tool development.

You will guide SDTM/ADaM datasets, generate TLFs for submissions, mentor teams, and help build reusable macros and templates.