Clinical Application Specialist III

job summary:
Step into a high-impact role where your expertise in statistical programming directly contributes to the development of life-changing therapies. As a Clinical Application Specialist III, you will join a collaborative team dedicated to excellence in clinical trial data analysis, working within a sophisticated SAS environment to transform complex datasets into meaningful insights. This position offers the chance to work at the forefront of pharmaceutical innovation, ensuring the highest standards of quality and regulatory compliance in a fast-paced, mission-driven atmosphere.

You will be part of an organization that operates out of state-of-the-art research and development hubs across the US, including major sites in Lake County, San Francisco, and New Jersey, providing a robust infrastructure for scientific discovery. This fully remote opportunity allows you to leverage industry-leading tools like SAS Enterprise Guide and Unix while collaborating with top-tier statisticians and programmers to advance global health outcomes.

location: Telecommute
job type: Contract
salary: $65.00 - 75.16 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Generate and validate CDISC-compliant datasets and TLFs (Tables, Listings, and Figures) for clinical trials using SAS.
• Develop and review ADaM specifications and programming to support both safety and efficacy analyses.
• Perform additional quality reviews of statistical programming deliverables to ensure accuracy and submission readiness.
• Collaborate closely with study lead programmers, statisticians, and data management personnel to meet project milestones.
• Interpret Pinnacle 21 results and utilize internal macros to maintain data integrity and standard compliance.
• Support regulatory submission activities, including ISS and ISE ADaM programming where applicable.

qualifications:
Required Skills

• SAS Proficiency: Minimum 5+ years (with MS) or 8+ years (with BS) of statistical programming experience using SAS, specifically within a UNIX environment.
• CDISC Standards: Extensive knowledge of CDISC, ADaMIG, and hands-on experience with ADaM specification and generation.
• Clinical Trials: Proven experience supporting clinical trial data analysis within the pharmaceutical or a related industry.
• Education: MS in Statistics, Computer Science, or related field with 5+ years' experience OR a BS in a STEM field with 8+ years' experience.
• Communication: Strong teamwork and communication skills for interacting with cross-functional data teams.

Preferred Skills

• Therapeutic Area: Oncology experience or specialized knowledge.
• Submission Experience: Background in supporting ISS/ISE and regulatory submissions.
• Software: Experience with SAS Enterprise Guide (EG) or SAS Studio.
• Certification: Professional SAS certification.

#LI-BM1

skills: SAS, Oncology, ADaM, CDISC


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.