The Opportunity:
On behalf of our client, a distinguished clinical biostatistics and programming organization, we are seeking a highly experienced and independent Principal Statistical Programmer.
Our client has a long-standing reputation for excellence and integrity, providing essential support for pharmaceutical companies navigating the regulatory approval process.
In this role, you will serve as the lead SAS programming expert for assigned clinical studies.
You will be responsible for ensuring the quality and accuracy of all programmed deliverables, playing a critical part in the successful submission of clinical trial data to regulatory authorities.1
What We Offer:
- Permanent Contract (Contrato a Término Indefinido): We offer long-term job stability from day one, including all legal benefits (prestaciones de ley) such as social security, pension contributions, severance pay (cesantías), and more.
- 100% Remote Work: This is a fully remote position, offering you the flexibility to work from anywhere within Colombia.
- Company Equipment Provided: We will provide all necessary high-performance equipment to ensure you have a productive and successful home office setup.
- Competitive & Negotiable Salary: We are committed to hiring top talent and offer a strong compensation package that is open to negotiation based on your skills and experience.
Key Responsibilities:
- Act as Lead Programmer: Serve as the lead statistical programmer on clinical projects, working autonomously to manage all programming deliverables and timelines.2
- Develop & Validate: Develop, test, and validate SAS programs to create and document analysis datasets (SDTM, ADaM) according to CDISC standards.3
- Generate Outputs: Produce and perform quality control on Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
- Provide Expertise: Offer expert review and programming input on protocols, statistical analysis plans (SAPs), and other key study documents.
- Ensure Compliance: Guarantee that all programming activities and documentation adhere to industry standards and regulatory requirements.
Qualifications and Experience:
- A BS or MS degree in Computer Science, Statistics, a related health science field, or equivalent experience.
- A minimum of 5 years of SAS programming experience working directly with clinical trial data.
- Expert-level knowledge of the drug development process and FDA/ICH guidelines.4
- Mastery of CDISC standards (SDTM and ADaM).5
- A proven track record of working independently and delivering high-quality results in a remote setting.
If you are a senior SAS programmer seeking an autonomous role where your expertise is central to success, we encourage you to apply.
Job Type: Full-time
Application Question(s):
- How many years of direct SAS programming experience do you have within the pharmaceutical or CRO industry, specifically working on clinical trial data?