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Remote Sdtm information

What is the difference between Remote Sdtm vs Remote Clinical Data Coordinator?

AspectRemote SdtmRemote Clinical Data Coordinator
CertificationsCDISC SDTM, CDMPCDISC SDTM, CDMP
Work EnvironmentRemote, data management teamsRemote, clinical data management teams
Industry UsagePharmaceutical, biotechPharmaceutical, biotech
Primary ResponsibilitiesDesign, validate SDTM datasetsManage, clean, and verify clinical data

Remote Sdtm specialists focus on creating and validating SDTM datasets for clinical trials, while Remote Clinical Data Coordinators handle overall data management, including data entry, cleaning, and verification. Both roles require similar certifications and work in the same industry, but their core tasks differ in scope and focus.

How does a Remote SDTM professional typically collaborate with cross-functional teams to ensure accurate clinical data submission?

As a Remote SDTM (Study Data Tabulation Model) professional, you will regularly work with clinical data managers, biostatisticians, and programmers to ensure that clinical trial data is accurately mapped and compliant with regulatory standards. Collaboration often involves virtual meetings, shared documentation, and version control tools to review data mappings and resolve discrepancies. Clear communication and proactive problem-solving are vital, as much of the alignment happens remotely. You'll also participate in data validation and quality control processes to support successful data submissions to regulatory authorities.

What are the key skills and qualifications needed to thrive as a Remote SDTM (Study Data Tabulation Model) Specialist, and why are they important?

To thrive as a Remote SDTM Specialist, you need strong expertise in clinical data management, SDTM standards, and familiarity with regulatory requirements, often supported by a degree in life sciences or a related field. Proficiency in tools like SAS, clinical data management systems (CDMS), and CDISC-compliant software is typically required. Excellent attention to detail, problem-solving abilities, and effective remote communication skills help individuals excel in this role. These competencies ensure accurate data standardization, regulatory compliance, and seamless collaboration within distributed teams.

What is a Remote SDTM professional?

A Remote SDTM (Study Data Tabulation Model) professional is a specialist who works remotely to standardize and organize clinical trial data according to the SDTM guidelines set by the Clinical Data Interchange Standards Consortium (CDISC). This role is crucial in preparing datasets for regulatory submissions by ensuring that data collected in clinical studies is consistently formatted and easily understood. Remote SDTM professionals are responsible for mapping raw clinical data into SDTM domains, performing quality checks, and collaborating with data managers and statisticians. Working remotely allows them to support clinical trials for pharmaceutical or biotechnology companies from anywhere, using secure digital tools.
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Remote Sdtm jobs near you
Infographic showing various Remote Sdtm job openings in California as of July 2026, with employment types broken down into 86% Full Time, 10% Part Time, and 4% Contract. Highlights an 59% Physical, 4% Hybrid, and 37% Remote job distribution.

Senior Manager, Statistical Programming - Job ID: 1646

Ascendis Pharma

Palo Alto, CA • On-site, Remote

$180K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 22 days ago

Job 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

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