A CDISC SDTM specialist is a key team member on CDISC submission topics; provide industry leading CDISC expertise and programming leadership. They contribute to process improvements and initiatives ...
A CDISC SDTM specialist is a key team member on CDISC submission topics; provide industry leading CDISC expertise and programming leadership. They contribute to process improvements and initiatives ...
Sr. SAS Programmer - Pharma
San Diego, CA · On-site
Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets. * Following statistical analysis plans and the Analysis Data Model (ADaM ...
Sr. SAS Programmer - Pharma
San Diego, CA · On-site
Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets. * Following statistical analysis plans and the Analysis Data Model (ADaM ...
This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization ...
This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization ...
This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization ...
This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization ...
This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization ...
This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
Associate Director/Director, Statistical Programming
South San Francisco, CA · On-site
$180K - $250K/yr
Author and review SDRG, ADRG, and dataset specifications (SDTM and ADaM) to ensure compliance, traceability, and submission readiness * Develop, validate, and maintain CDISC-compliant datasets (SDTM ...
Associate Director/Director, Statistical Programming
South San Francisco, CA · On-site
$180K - $250K/yr
Author and review SDRG, ADRG, and dataset specifications (SDTM and ADaM) to ensure compliance, traceability, and submission readiness * Develop, validate, and maintain CDISC-compliant datasets (SDTM ...
Biostatistician
Charleston, WV · On-site
Learns the role that SDTM & ADaM plays in the standardization of clinical trials data/CDISC. * Able to prepare specifications for simple analysis data sets (CDISC and CDISC-like) independently or ...
Biostatistician
Charleston, WV · On-site
Learns the role that SDTM & ADaM plays in the standardization of clinical trials data/CDISC. * Able to prepare specifications for simple analysis data sets (CDISC and CDISC-like) independently or ...
This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization ...
Quick apply
This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization ...
Clinical SAS Developer
Upper Gwynedd, PA · On-site
$43 - $48/hr
Strong knowledge of SDTM. * Extensive programming experience in a clinical trial environment (CRO/Pharma). * Expertise in SAS/BASE, SAS/STAT, and SAS/MACRO. * In-depth knowledge of CDISC standards ...
Quick apply
Clinical SAS Developer
Upper Gwynedd, PA · On-site
$43 - $48/hr
Strong knowledge of SDTM. * Extensive programming experience in a clinical trial environment (CRO/Pharma). * Expertise in SAS/BASE, SAS/STAT, and SAS/MACRO. * In-depth knowledge of CDISC standards ...
Manager/Senior Manager Statistical Programmer
Boston, MA · On-site
$120K - $144K/yr
Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance. * Create, validate, update, and document SAS programs to generate ...
Manager/Senior Manager Statistical Programmer
Boston, MA · On-site
$120K - $144K/yr
Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance. * Create, validate, update, and document SAS programs to generate ...
Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance. * Create, validate, update, and document SAS programs to generate ...
Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance. * Create, validate, update, and document SAS programs to generate ...
Integrate new data standard releases with clinical study level SDTM deliverables to ensure seamless integration. Develop programs and utilities using various tools and languages to support ...
Integrate new data standard releases with clinical study level SDTM deliverables to ensure seamless integration. Develop programs and utilities using various tools and languages to support ...
Associate Director/Director, Statistical Programming
South San Francisco, CA · On-site
$180K - $250K/yr
Author and review SDRG, ADRG, and dataset specifications (SDTM and ADaM) to ensure compliance, traceability, and submission readiness * Develop, validate, and maintain CDISC-compliant datasets (SDTM ...
Associate Director/Director, Statistical Programming
South San Francisco, CA · On-site
$180K - $250K/yr
Author and review SDRG, ADRG, and dataset specifications (SDTM and ADaM) to ensure compliance, traceability, and submission readiness * Develop, validate, and maintain CDISC-compliant datasets (SDTM ...
Senior Manager, Statistical Programming - Job ID: 1646
Palo Alto, CA · On-site
$180K/yr
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 ...
Quick apply
Senior Manager, Statistical Programming - Job ID: 1646
Palo Alto, CA · On-site
$180K/yr
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 ...
Principal Statistical Programmer
$98K - $273K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Principal Statistical Programmer
$98K - $273K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Senior Manager, Statistical Programming - Job ID: 1646
Palo Alto, CA · On-site
$180K/yr
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 ...
Senior Manager, Statistical Programming - Job ID: 1646
Palo Alto, CA · On-site
$180K/yr
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 ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
Senior Manager, Statistical Programming - Job ID: 1646
Palo Alto, CA · On-site +1
$180K/yr
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 ...
Senior Manager, Statistical Programming - Job ID: 1646
Palo Alto, CA · On-site +1
$180K/yr
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 ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
Sdtm information
See salary details
$19.23 - $24.78
4% of jobs
$24.78 - $30.33
9% of jobs
$30.33 - $35.88
4% of jobs
$35.88 - $41.43
7% of jobs
$41.78 is the 25th percentile. Wages below this are outliers.
$41.43 - $46.98
9% of jobs
The median wage is $52.53 / hr.
$46.98 - $52.53
17% of jobs
$52.53 - $58.09
7% of jobs
$58.09 - $63.64
14% of jobs
$65.40 is the 75th percentile. Wages above this are outliers.
$63.64 - $69.19
12% of jobs
$69.19 - $74.74
10% of jobs
$74.74 - $80.29
7% of jobs
$19
$54
$80
How much do sdtm jobs pay per hour?
What is an SDTM job?
An SDTM job involves working with the Study Data Tabulation Model (SDTM), a standardized format required by regulatory agencies like the FDA for clinical trial data submission. Professionals in this role convert raw clinical data into SDTM-compliant datasets, ensuring consistency, traceability, and adherence to regulatory guidelines. Responsibilities often include data mapping, validation, and quality control to facilitate efficient review by regulatory bodies.
What are the key skills and qualifications needed to thrive in the Sdtm position, and why are they important?
To thrive as an SDTM (Study Data Tabulation Model) Programmer, you need a strong background in clinical data standards, SAS programming, and an understanding of FDA submission requirements, usually supported by a degree in a scientific, mathematical, or computer-related field. Expertise with CDISC standards, SDTM IGs (Implementation Guides), and tools such as Pinnacle 21 Validator or JReview is essential. Strong analytical skills, attention to detail, effective communication, and the ability to collaborate across multidisciplinary teams are vital soft skills. These competencies are crucial for ensuring high-quality, regulatory-compliant clinical trial data that supports successful drug approval processes.
What are the typical daily responsibilities of an SDTM Programmer in a clinical research organization?
As an SDTM Programmer, your daily tasks often include mapping raw clinical data into SDTM domains, validating datasets for compliance with CDISC standards, and generating documentation and specifications for regulatory submissions. You’ll frequently work with clinical data managers, statisticians, and other programmers to ensure data integrity and resolve any data-related queries that arise. Collaboration and timely troubleshooting are key, as your work supports the efficient progression of clinical studies through regulatory review. The role tends to be dynamic and deadline-driven, making organizational skills and adaptability important for success.

Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 21 days ago
Job description
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.
Why ImmunityBio?
• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.
Position Summary
A Principal Statistical Programmer is an expert in management, technical oversight, and quality of statistical programming activities related to the analyses of clinical trial data ensuring timelines and company strategic objectives are met. A CDISC SDTM specialist is a key team member on CDISC submission topics; provide industry leading CDISC expertise and programming leadership. They contribute to process improvements and initiatives within the Biometrics department as well as mentor and train junior staff members as applicable.
Essential Functions
- Lead all aspects of the statistical programming activities including efficient programming techniques.
- Lead all aspects of creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
- Contribute to and review of statistical analysis plans and analysis datasets specifications and prepare the electronic submission of clinical trial data to regulatory authorities.
- Create specifications, develop, and validate of CDISC SDTM and regulatory deliverables (Define.xml, SDTM aCRF, cSDRG).
- Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions). Communicate with regulatory agencies regarding electronic data submission requirements.
- Participate effectively as an ad-hoc member on clinical development and regulatory submission teams.
- Provide effective solutions for complex statistical programming tasks.
- Create and manage projects and study electronic subdirectories ensuring consistency in structure.
- Contribute to the design, creation, and validation of global programming macros that streamline programming activities and increase efficiency.
- Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation within a project
- Conduct resource planning and budgeting for statistical programming activities of a project.
- Participate in development of new processes or revision of existing processes.
- Keep current with new statistical programming techniques and technical advancements.
- As necessary, provide work direction, guidance, mentoring, influence and support to junior staff. Train junior staff in more complex statistical programming techniques.
- Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
- Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.
Education & Experience
- Bachelor's Degree in Statistics/Biostatistics, Computer Science, Mathematics or other field of study with at least 10+ years of relevant experience is required, OR
- Master's Degree in Statistics/Biostatistics, Computer Science, Mathematics or other field of study with at least 8+ years of relevant experience is required.
- 5+ years of experience as a statistical programmer in the pharmaceutical industry is preferred.
- Expert in CDISC STDM guidelines
- Expert in CDISC SDTM regulatory deliverables (Define.xml, SDTM aCRF, cSDRG)
- Experience as a lead statistical programmer on several concurrent projects
Knowledge, Skills, & Abilities
- Working knowledge of the clinical research, Good Clinical Practices, and regulatory requirements/guidelines.
- Technically strong with regard to statistical programming processes and activities.
- Highly proficient in SAS.
- Excellent English verbal and written communication skills; good organizational and interpersonal skills.
Working Environment / Physical Environment
- This position works onsite or remotely depending on the candidate's geographic location.
- Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
- Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
- Lift and carry materials weighing up to 20 pounds.
Employee, Regular: Salary
This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
National Market (all markets unless identified as Premium)
$162,000 (entry-level qualifications) to $180,000 (highly experienced) annually
Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)
$171,000 (entry-level qualifications) to $190,000 (highly experienced) annually
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
About ImmunityBio
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
San Diego, CA, US
Year founded
2014