Senior Manager, Statistical Programming - Job ID: 2068

Ascendis Pharma A/S

Palo Alto (CA)

Híbrido

USD 170.000 - 180.000

Jornada completa

Hace 4 días

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Ventajas ofrecidas por este puesto de trabajo

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

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Descripción de la vacante

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.

Formación

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.

Responsabilidades

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.

Conocimientos

SAS programming

CDISC SDTM/ADaM

Lead programmer

Regulatory submissions

Biotech/pharma domain

Python

Git

Team leadership

Educación

Bachelor’s degree in Statistics, Mathematics, Computer Science

Master’s degree in relevant field

Herramientas

SAS

Python

Git

Descripción del empleo

Ascendis 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 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, 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.

Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field with at least 10 years of programming experience in the pharmaceutical or biotech industry; or a 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, including SDTM and ADaM.
Understanding of the clinical drug development process and regulatory requirements.
Proficiency in SAS programming, including the ability to develop and validate reusable macros.
Familiarity with other programming languages or tools (e.g., R, Python, Git, VB) is a plus.
Experience contributing to departmental tools (e.g., macro libraries, specification templates, or automation tools) is preferred.
Strong verbal and written communication skills, with 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.

The estimated salary range for this position is $170-180K/year. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock‑based long‑term incentives, paid time off, and a comprehensive benefits package.