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Clinical Statistical Programmer Jobs in Washington

Otsuka

Associate Director, Biostatistics

Rockville, MD · On-site +1

... phase clinical data. Skills * In-depth knowledge of statistical principles, applications, and SAS/R programming software. * Strong computer skills with demonstrated experience in working with the ...

Otsuka

Associate Director, Biostatistics

Rockville, MD · On-site +1

... and clinical operation. * Familiar with regulatory submission process in US and EU. Skills * In-depth knowledge of statistical principles, applications, and SAS/R programming software. * Strong ...

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Clinical Statistical Programmer information

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How much do clinical statistical programmer jobs pay per hour?

As of Jun 16, 2026, the average hourly pay for clinical statistical programmer in Washington is $61.36, according to ZipRecruiter salary data. Most workers in this role earn between $38.94 and $92.31 per hour, depending on experience, location, and employer.

What are some common challenges faced by Clinical Statistical Programmers when working with clinical trial data?

Clinical Statistical Programmers often encounter challenges such as handling large and complex datasets, ensuring data integrity, and adhering to strict regulatory guidelines (like CDISC standards). Collaborating closely with biostatisticians, data managers, and clinical teams is essential to resolve data discrepancies and meet tight project deadlines. Staying updated on evolving regulatory requirements and software tools is also vital to maintain high-quality deliverables in a fast-paced environment.

What are the key skills and qualifications needed to thrive as a Clinical Statistical Programmer, and why are they important?

To thrive as a Clinical Statistical Programmer, you need strong proficiency in statistical programming languages (such as SAS or R), a background in statistics or life sciences, and familiarity with clinical trial processes. Experience with CDISC standards (SDTM, ADaM), regulatory submission requirements, and version control systems is highly valued. Attention to detail, problem-solving abilities, and effective communication are crucial soft skills for collaborating with cross-functional teams and ensuring data quality. These skills ensure the accurate analysis and reporting of clinical data, which is critical for regulatory compliance and successful clinical trial outcomes.

What does a Clinical Statistical Programmer do?

A Clinical Statistical Programmer is responsible for managing and analyzing clinical trial data using statistical software, such as SAS or R. Their primary tasks include creating datasets, programming statistical analyses, and generating tables, listings, and figures for clinical study reports. They work closely with biostatisticians and clinical research teams to ensure data accuracy and regulatory compliance. Their work is essential for supporting submissions to regulatory agencies and for making data-driven decisions in clinical research.

What Does a Clinical Statistical Programmer Do?

The job duties of a clinical statistical programmer involve collecting data, performing statistical analysis, and analyzing data sets according to the needs of their employer or client. Your responsibilities in this career may involve using SAS programming to create and analyze data sets during clinical trials or other clinical experiments and studies. You may also be involved in performing data integration for reports following clinical research or statistical analysis for quality control (QC).

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Clinical Statistical Programmer jobs near you
Clinical Trial Biostatistician

Clinical Trial Biostatistician

Cherokee Federal

Bethesda, MD • On-site

Part-time

Medical, Dental, Vision, Retirement

Posted 28 days ago

Job description

Job Description
The Biostatistician will provide statistical and statistical-programming support for a Phase 2a randomized, double-blind clinical trial evaluating a hantavirus vaccine for the prevention of Hemorrhagic Fever with Renal Syndrome (WRAIR 2725). The Biostatistician will develop FDA-ready, CDISC-compliant deliverables, execute analyses per the approved Statistical Analysis Plan (SAP), and support generation of regulatory-submission outputs required for FDA filing and study close-out.
This is a fractional, deliverable-driven role with workload concentrated around dataset development, validation, and analysis milestones. Work supports Force Health Protection research and directly enables WRAIR's regulatory submission.
Compensation & Benefits:
Estimated Starting Salary Range: TBD
Pay commensurate with experience.
Full time benefits include Medical, Dental, Vision, 401K and other possible benefits as provided. Benefits are subject to change with or without notice.
Clinical Biostatistician Responsibilities Include:
Statistical Programming & Validation
  • Develop, program, and validate CDISC SDTM datasets from raw clinical data (e.g., demographics, adverse events, labs, vitals, concomitant medications).
  • Develop, program, and validate CDISC ADaM datasets to support planned analyses.
  • Maintain end-to-end traceability between raw data, SDTM, ADaM, and TLF outputs.
  • Perform independent QC and validation checks to ensure accuracy, completeness, and reproducibility.

Metadata & Submission Documentation
  • Create and maintain Define.XML for SDTM and ADaM deliverables.
  • Prepare the Study Data Reviewer's Guide (SDRG) for SDTM datasets.
  • Prepare the Analysis Data Reviewer's Guide (ADRG) for ADaM datasets.
  • Produce annotated CRFs mapping collection fields to SDTM variables and controlled terminology where applicable.

Statistical Analysis & Reporting
  • Review protocol, SAP, SOPs, and study-specific procedures; provide written notification of review and understanding.
  • Execute statistical analyses in full alignment with the approved SAP.
  • Produce Tables, Listings, and Figures (TLFs) and contribute statistical output and narrative content for the Final Clinical Study Report (FCSR) for regulatory submission.

Quality Assurance & Compliance
  • Ensure all deliverables meet current FDA CDISC standards and related guidance (including define/guide conventions and annotation expectations).
  • Produce documentation demonstrating CDISC compliance and audit readiness.
  • Meet performance expectations, including a 95% compliance standard against deliverable requirements, on-time submission, and minimal need for substantive revision.

Project Coordination & Communication
  • Coordinate with WRAIR CTC staff on data transfers, review cycles, and issue resolution.
  • Provide routine status updates on progress, risks, and dependencies; support inputs to the Program Management Plan (PMP) and Monthly Status Reports (MSRs).
  • Communicate effectively with Government leaders, scientists, and stakeholders; clearly identify contractor status in all interactions.

Indicative Deliverable Timeline (from study review start)
  • SDTM + ADaM datasets, Define.XML, SDRG, ADRG, annotated CRF: within 3 months
  • Statistical analyses completed: within 8 months
  • FCSR statistical deliverables completed: within 11 months

Clinical Biostatistician Experience, Education, Skills, Abilities requested:
Required Qualifications
  • Master's degree in Biostatistics, Statistics, or closely related quantitative field (or equivalent combination of education and experience).
  • Demonstrated experience producing CDISC-compliant SDTM and ADaM datasets and associated metadata/documents.
  • Strong statistical programming skills for clinical trials; SAS strongly preferred.
  • Working knowledge of FDA submission expectations for study data standards and documentation (Define.XML, SDRG/ADRG, CRF annotation).
  • Knowledge of GCP, ICH guidelines, and applicable 21 CFR requirements (including Parts 11, 50, 56, and 312).
  • Proficiency with Microsoft Office (Outlook, Word, PowerPoint, Excel) and Adobe PDF tools.
  • Strong written and verbal communication skills; able to operate effectively with Government stakeholders and cross-functional study teams.
  • Ability to work independently, manage shifting priorities, and deliver high-quality work on schedule in a deadline-driven environment.

Preferred Qualifications
  • PhD in Biostatistics or Statistics.
  • Experience supporting vaccine, infectious disease, and/or Phase 2 clinical trials.
  • Prior experience preparing statistical content for FDA regulatory submissions and clinical study reports.
  • Familiarity with DoD/military medical research environments and terminology.

Minimum Security Level:
  • Favorable Tier 1 NACI (or equivalent/higher) completed prior to start, or an open/pending investigation with no unfavorable information, as allowed by the customer.
  • Ability to obtain and maintain a Common Access Card (CAC) for on-site facility and network access.
  • Must be able to complete a National Agency Check and obtain installation access at WRAIR.
  • Mut pass pre-employment requirements of Cherokee Federal.

Company Information:
Cherokee Nation Integrated Health (CNIH) is a part of Cherokee Federal - the division of tribally owned federal contracting companies owned by Cherokee Nation Businesses. As a trusted partner for more than 60 federal clients, Cherokee Federal LLCs are focused on building a brighter future, solving complex challenges, and serving the government's mission with compassion and heart. To learn more about CNIH, visit cherokee-federal.com.
#CherokeeFederal #LI
Cherokee Federal is a military friendly employer. Veterans and active military transitioning to civilian status are encouraged to apply.
Legal Disclaimer: Cherokee Federal is an equal opportunity employer. Please visit cherokee-federal.com/careers for information regarding our Affirmative Action and Equal Opportunity Employer Statement, and Accommodation request.
Many of our job openings require access to government buildings or military installations. Candidates must pass pre-employment qualifications of Cherokee Federal.
Please Note:This position is pending a contract award.If you are interested in a future with Cherokee Federal, APPLY TODAY!Although this is not an approved position, we are accepting applications for this future and anticipated need.
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About Cherokee Federal

Sourced by ZipRecruiter

Cherokee Federal - a division of Cherokee Nation Businesses - is a team of tribally owned federal contracting companies focused on building solutions, solving complex challenges, and serving the nation's mission around the globe for more than 60 federal clients. Our team of companies manages nearly 1,000 projects of all sizes across the construction, consulting, engineering and manufacturing, health, and technology portfolios. Since 2012, the Cherokee Federal team of companies has won more than $5 billion in government contracts. Our 3,000+ employees work in 26 countries, 50 states and 2 U.S. territories. Why choose Cherokee Federal? Visit our website and learn about the great reasons to join our team. cherokee-federal.com

Industry

Architectural services

Company size

1,001 - 5,000 Employees

Headquarters location

Tulsa, OK, US

Year founded

1969

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