Senior/Principal Statistical Programmer Contractor - Remote

<p><strong>About the job</strong></p><p>This is a <strong>Contractor - Senior statistical programmer - Remote position in a pharmaceutical company</strong>. This position will play a key role in the development, validation, and maintenance of clinical trial data analyses. This position ensures compliance with CDISC standards, adherence to regulatory requirements, and efficient execution of statistical programming deliverables. The role involves developing and validating datasets, tables, listings, and figures (TLFs) to support drug development and regulatory submissions for multiple indications.</p><p><strong>Key Responsibilities</strong></p><ul><li>Develop and validate <strong>SDTM </strong>and <strong>ADaM </strong>datasets in accordance with <strong>CDISC standards</strong>.</li><li>Generate high-quality <strong>tables, listings, and figures (TLFs) </strong>for clinical study reports and regulatory submissions.</li><li>Ensure the accuracy, quality, and timeliness of statistical analyses and deliverables.Perform rigorous quality control (QC) checks on all programming outputs.</li><li>Troubleshoot and resolve data and programming issues efficiently.</li><li>Collaborate with cross-functional study teams to support accurate and consistent data reporting.</li><li>Promote programming best practices by demonstrating strong technical expertise in statistical programming environments and tools.</li><li>Lead, mentor, and provide guidance to junior programming staff, fostering technical and professional development.</li><li>Ensure full compliance with regulatory submission requirements and CDISC standards (SDTM, ADaM).</li></ul><p><strong>Qualifications</strong></p><ul><li>Bachelor’s or Master’s degree in Statistics, Computer Science, or a related field.</li><li>Minimum <strong>8 years of relevant experience</strong> in the biopharmaceutical, biotechnology, or CRO industry.</li><li>Experience in late-phase (phase III) trials is highly desirable.</li><li><strong>Proficiency in SAS programming</strong>.</li><li>Hands-on experience with raw datasets, SDTM, and ADaM dataset development.</li><li>Strong analytical, problem-solving, and communication skills (both verbal and written).</li><li>Ability to work effectively in a cross-functional environment, proactively influencing teams with innovative clinical development strategies.</li></ul>

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...

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