Senior Manager, Statistical Programming - Job ID: 2068

Ascendis Pharma•Palo Alto, CA

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 therapies addressing unmet medical needs and offers a dynamic workplace for employee growth and development. The Senior Manager, Statistical Programming provides timely, strategic programming support to clinical study teams in alignment with project goals. The role combines hands-on programming with leadership in study execution and tool development. As Statistical Programming Lead for one or more clinical trials, this person is responsible for programming deliverables from study start through regulatory submission. The role also supports development and maintenance of departmental programming tools, including standard macros and SDTM and ADaM specification templates. It requires expertise in CDISC standards, strong communication and leadership skills, and an understanding of clinical trial data and analysis workflows. 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 pharmaceutical or biotech programming experience; 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 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 Statistical Programming Lead for clinical trials and oversee 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 in accordance with 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 promote 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.

Benefits

401(k) plan with company match
Medical, dental, and vision plans
Company-offered life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short- and long-term disability benefits
Pet insurance
Legal insurance
Employee Assistance Program
Employee discounts
Professional development
Health Savings Account (HSA)
Flexible Spending Accounts
Various incentive compensation plans
Accident, Critical Illness, and Hospital Indemnity Insurance
Mental health resources
Paid leave benefits for new parents
Paid time off
Potential eligibility for a discretionary annual bonus or incentive compensation plan
Potential eligibility for discretionary stock-based long-term incentives