Senior Manager, Statistical Programming: Job ID - 1646

Description

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.

Requirements

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.

Salary Range: $170-180K/year

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

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
Unique offerings of Pet Insurance and Legal Insurance
Employee Assistance Program
Employee Discounts
Professional Development
Health Saving 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

Life at Ascendis Pharma

Thrive Here & What We ValueCollaborative work environment | Opportunities for professional growth and development | Flexible work schedule options | Recognition for outstanding performance</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patient's lives | Guided by core values of Patients, Science, and Passion | Use TransCon® drug development platform to fulfill mission of developing new therapies | Advancing programs in Endocrinology Rare Disease and Oncology | Collaborating with partners around the world on the development of TransCon-based products for other therapeutic areas and markets | Seeking passionate People Leader to join growing function | Part of People Leader community with three People Leaders based in Hellerup and Princeton, US | Responsible for well-being and personal development of team members in Denmark | Work closely with Lene Rhein Larsen, People Leader, to continuously improve governance and people processes | Report to Lars Tranberg Pettersson, CIO and work out of our Hellerup office.</s> | Dynamic Workplace for Employees to Grow and Develop Their Skills | TransCon® Drug Development Platform to Fulfill Mission of Developing New and Potentially Best-in-class Therapies to Address Unmet Medical Needs | Exceptional Science, Visionary Leadership, and Skilled and Passionate Colleagues | Collaborative Environment for Skilled, Adaptable, and Highly Resourceful Professionals to Make Their Mark</s> | 1. Entrepreneurial and international company | 2. Short line of command | 3. GCP & GVP regulated environment | 4. Exciting product pipeline | 5. Highly skilled and experienced colleagues</s> | Collaborative culture on an accountability-based team | Unique offerings of Pet Insurance and Legal Insurance | Employee Assistance Program | Employee Discounts | Professional Development | Health Saving 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</s> | 1. Guided by our core values of Patients, Science, and Passion | 2. Use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate bestin-class potential to address unmet medical needs. | 3. Advancing programs in Endocrinology Rare Disease and Oncology. | 4. Collaborating with partners around the world on the development of TransConbased products for other therapeutic areas and markets.</s> | 1. PatientCentric Approach | 2. ScienceDriven Innovation | 3. Passionate Team Members | 4. Collaborative Environment | 5. Dynamic Role</s> | Use TransCon® drug development platform to fulfill mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs | Collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets</s> | Fast-paced environment with cross-functional, global teams | Collaborative, international and informal environment where we challenge and learn from each other</s> | Patient-centric, science-based, performance-driven | Creating an outstanding workplace</s> | Patient-centric approach to drug development | Emphasis on innovation and scientific excellence | Collaborative work environment with opportunities for professional growth | Focus on making a meaningful difference for patients through our innovative TransCon technology platform | Strong commitment to employee well-being and work-life balance</s> | Visionary leadership</s> | Fostering a place where skilled, adaptable, and highly resourceful professionals can truly make their mark | Using TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs | Advancing programs in Endocrinology Rare Disease and Oncology</s> | Dynamic, fast-growing global biopharmaceutical company | Onsite presence in our Palo Alto, CA office 3 times per week or more, as necessary | Travel within the US &/or to our corporate headquarters in Denmark may be necessary | Focuses on exceptional science, visionary leadership, and skilled and passionate colleagues. | Uses TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs. | Fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. | Offers dynamic workplace for employees to grow and develop their skills.</s> | Culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark.</s> | Dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States | Providing strategic leadership to ensure the successful design and execution of non-clinical and clinical trials as well as Life Cycle Management Strategies | Engaging closely with internal peers and externally stakeholders such as the FDA, EMA, and other key regulatory bodies | Formulating strategies, enhancing performance, implementing relevant policies, and providing key insights that enable the organization to operate collaboratively and proactively.</s>