Statistical Programmer

Digital Prospectors; Bedford (MA); Remote; USD 80,000 - 100,000; Full time

Job summary

A clinical research organization is seeking a skilled Statistical Programmer to provide programming support for Phase 1 through Phase 3 clinical trials. The role involves developing annotated CRFs and SDTM datasets while ensuring compliance with project requirements. Candidates should have a Master’s degree in a relevant field and experience in SAS programming. This position offers remote work flexibility and the chance to contribute to impactful clinical research.

Qualifications

• 1-5 years of experience in clinical trial programming within the biotechnology, pharmaceutical, or healthcare industry.
• Experience working with cross-functional teams to ensure project alignment and timely execution.
• Knowledge of process improvement strategies within statistical programming is a plus.

Responsibilities

• Lead programming efforts for various clinical studies, from Phase 1 to Phase 3.
• Develop and review annotated Case Report Forms (CRFs) and SDTM datasets.
• Program SDTM, ADaM, and TLFs, and write detailed dataset specifications.

Skills

SAS programming

Expertise in statistical software such as R or S-Plus

Organizational skills

Ability to work independently

Education

Master's degree in Statistics, Computer Science, Mathematics, Engineering, or related field

Tools

CDISC standards (SDTM, ADaM)

Job description

Position: Statistical Programmer

Location: Bedford, MA (Remote)

Length: 6+ months

*W2 Candidates Only, No C2C

Job Description: Our client is seeking a skilled Statistical Programmer to join their team. In this role, you will provide programming support for Phase 1 through Phase 3 clinical trials, focusing on disease monitoring and project integration. As a key member of the Biometrics team, you will work collaboratively across multiple projects and therapeutic areas, ensuring the timely delivery of statistical data and analysis. This position offers the flexibility of remote work, with the chance to contribute to cutting-edge research in a dynamic and evolving environment.

Essential Duties and Responsibilities:

• Lead programming efforts for various clinical studies, from Phase 1 to Phase 3, across multiple therapeutic areas.
• Develop and review annotated Case Report Forms (CRFs) and SDTM datasets, ensuring accurate data representation.
• Program SDTM, ADaM, and TLFs, and write detailed dataset specifications.
• Perform quality control on datasets and tables, ensuring compliance with project requirements.
• Work closely with Clinical Operations, Clinical Data Management, Drug Safety, Regulatory Affairs, and Project Management teams to ensure the timely and accurate delivery of statistical programming work.
• Provide technical input on documentation produced by other functions, including biostatisticians, medical writers, and data managers.
• Ensure clear and effective communication regarding project progress, timelines, and any issues that may impact deliverables.
• Contribute to process improvement initiatives aimed at enhancing efficiency and quality in statistical programming.
• Identify new tools and technologies to optimize the programming workflow and improve deliverable quality.
• Serve as a mentor and role model, setting high expectations for quality, creativity, and ownership across projects.
• Manage competing priorities and foster a collaborative work environment to support project success.

Qualifications:

• Master's degree in Statistics, Computer Science, Mathematics, Engineering, or a related field.
• 1-5 years of experience in clinical trial programming within the biotechnology, pharmaceutical, or healthcare industry.
• Expertise in SAS programming, with proficiency in additional statistical software such as R or S-Plus.
• In-depth knowledge of CDISC standards, including SDTM, ADaM, and controlled terminologies.
• Strong organizational skills and the ability to prioritize and manage multiple tasks efficiently.
• Self-motivated, technically proficient, and able to work independently while maintaining a strategic perspective on statistical programming processes.
• Experience working with cross-functional teams to ensure project alignment and timely execution.
• Knowledge of process improvement strategies within statistical programming is a plus.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.