Senior Statistical Programmer - Remote

United States Digital Space LLC; United States; Remote; USD 100,000 - 140,000; Full time

Job summary

United States Digital Space LLC seeks an experienced Statistical Programmer to generate tables, listings and graphs from clinical trial data using SAS, following SDLC. Strong SAS Base and Macros, and knowledge of ICH/FDA GCP regulations are essential.

Masters in statistics or a related field is required, with 5+ years in statistical programming and experience with SDTM/ADaM standards and data pooling for regulatory submissions. Leadership of small teams is a plus.

Qualifications

• Masters required for statistics roles.
• Minimum 5 years’ experience in Statistical Programming or similar field.
• Expert knowledge of scientific principles and concepts.
• Familiarity with CROs, clinical data terminology, and drug development.

Job description

About the company

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? the company is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, the company not only maintains an industry-leading customer satisfaction rating but also foster a collaborative and inclusive work environment where employees can thrive. Join us at the company and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why the company is a great place to advance your career. Visit or follow the company on LinkedIn.

Applicants must be legally authorized to work in the U.S. for any employer; we cannot sponsor visas (e.g., H-1B) or offer work authorization transfers at this time.

Job Specific Skills

• Mastery and trained on generating tables, listings, and graphs from clinical trial databases using SAS.
• Utilizes System Development Life Cycle (SDLC) for programming deliverables.
• Advanced user in SAS programming, SAS Base, and SAS Macros.
• Advanced knowledge of E-Submission Standards, Guidelines and Regulations.
• Mastery and trained on SDTM standards including ability to write specifications.
• Advanced knowledge of ADaM standards including supporting specification writing.
• Proficient with MS Office applications.
• Advanced knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements.
• Advanced experience with pooling of data sets for submissions.
• Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP.
• Lead study or small programming project teams.

Job Requirements

• Masters required for all Statistics roles.
• Minimum of 5 years’ experience in Statistical Programming or similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.