Job Description
Location: Remote (home-based in the U.S.)Work Time Zone: Eastern Time Zone (EST)
Employment Type: 12-month contract (renewable)
About the Role:
We are seeking a highly skilled and self-motivated Senior SAS Programmer with extensive lead and co-lead experience, particularly in the oncology therapeutic area. The ideal candidate will be able to work independently, write specifications, and contribute to the overall success of our clients' clinical trials. (This position is for a client.)
Key Responsibilities:
Lead and Co-Lead Studies: Act as the Statistical Programming Lead or Co-Lead for clinical studies, collaborating closely with statisticians to ensure timely and accurate delivery of outputs. SAS Programming: Develop, test, and validate SAS programs to support clinical trials, ensuring high-quality data management and statistical analysis. Oncology Expertise: Apply your in-depth knowledge of oncology clinical trials to provide insights and support for study designs and analyses. Data Management and Analysis: Create and manage datasets, generate tables, listings, and figures, and ensure the integrity and accuracy of clinical trial data. Spec Writing: Write detailed specifications for datasets, outputs, and analysis, ensuring compliance with regulatory standards and guidelines. Independent Work: Demonstrate the ability to work independently, manage multiple tasks, and deliver results under tight timelines. Collaboration: Collaborate effectively with cross-functional teams, including Biostatistics, Clinical Data Management, Clinical Research, and Global Drug Safety. Process Improvement: Participate in process improvement initiatives, internal programming tasks, and presentations to internal committees and boards. Submission Activities: Participate in submission activities, including interim analysis (IA), clinical study reports (CSR), development safety update reports (DSUR), and FDA submissions.
Qualifications
Experience:
Over 15 years of total experience in the industry. Oncology Focus: At least 7-8 years of experience in oncology-focused clinical trials. Leadership: Proven experience leading and co-leading studies, managing multiple projects, and providing programming support.
Technical Skills:
Proficiency in SAS programming and a strong understanding of CDISC standards (SDTM, ADaM).
Education:
A master's or bachelor's degree in a relevant field or 18+ years of industry experience.
Soft Skills:
Strong communication and collaboration skills, self-motivation, and excellent time management and organizational abilities.
Required Skills:
Analysis Process ImprovementSASData Management Soft Skills Timelines Writing Specifications Programming Presentations Education Time Management Research Leadership Communication Management
