At a Glance
- Tasks: Support regulatory submissions and produce high-quality datasets with a focus on timelines.
- Company: Proclinical is a top life sciences recruiter connecting talent with leading global positions.
- Benefits: Enjoy flexible work locations and occasional travel for exciting events.
- Why this job: Join a dynamic team, lead projects, and make a real impact in the pharmaceutical industry.
- Qualifications: Degree in Computer Science or related field; SAS programming experience in pharma required.
- Other info: Act as a technical expert and provide training on industry standards.
The predicted salary is between 42000 - 84000 £ per year.
Proclinical is seeking a Statistical Programmer - Submissions for a Senior position. This role involves supporting regulatory submissions, producing and validating datasets, and ensuring high-quality outputs within set timelines. The position offers flexibility in work location and requires occasional travel for events.
Responsibilities:
- Program datasets including complex efficacy and lab data.
- Serve as an independent technical expert and program complex non-efficacy outputs.
- Conduct senior reviews and quality control of non-statistical outputs.
- Develop and implement standard macros and perform user acceptance testing.
- Create, QC, and update complex dataset specifications for various studies.
- Provide consultancy and training on SDTM, ADaM, and CRT standards.
- Stay informed on regulatory guidelines and implement PHASTAR CRT tools.
- Lead programming projects, ensuring quality and timely delivery.
- Collaborate with statisticians and project managers on resources and deliverables.
- Act as a point of contact for programming issues and ensure cohesive team operations.
- Develop and deliver company-wide training and update processes and SOPs.
Key Skills and Requirements:
- Degree in Computer Science or another relevant field.
- Experience in SAS programming within the pharmaceutical industry.
- Understanding of clinical trial design and regulatory submissions.
- Familiarity with GCP and regulatory requirements.
- Knowledge of SDTM and ADaM CDISC standards.
Senior or Principal Statistical Programmer - Submissions employer: Proclinical Staffing
Contact Detail:
Proclinical Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior or Principal Statistical Programmer - Submissions
✨Tip Number 1
Make sure to highlight your experience with SAS programming in the pharmaceutical industry during any networking opportunities. Connect with professionals in the field on platforms like LinkedIn and engage in discussions about regulatory submissions to showcase your expertise.
✨Tip Number 2
Stay updated on the latest regulatory guidelines and CDISC standards, particularly SDTM and ADaM. Consider joining relevant online forums or attending webinars to deepen your knowledge and demonstrate your commitment to continuous learning.
✨Tip Number 3
If you have the chance, attend industry conferences or events where you can meet potential employers face-to-face. This is a great way to network and discuss your skills in statistical programming directly with hiring managers.
✨Tip Number 4
Prepare to discuss specific projects where you've led programming efforts or conducted quality control. Be ready to share examples of how you've collaborated with statisticians and project managers to ensure timely delivery of high-quality outputs.
We think you need these skills to ace Senior or Principal Statistical Programmer - Submissions
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in SAS programming and your understanding of clinical trial design. Emphasise any previous roles where you supported regulatory submissions or worked with SDTM and ADaM standards.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the responsibilities mentioned in the job description. Discuss your experience with complex datasets, quality control, and your ability to lead programming projects.
Showcase Technical Expertise: In your application, provide examples of how you've served as a technical expert in previous roles. Mention any standard macros you've developed or user acceptance testing you've performed.
Highlight Collaboration Skills: Since the role involves collaboration with statisticians and project managers, include examples of successful teamwork in your application. This could be from past projects where you ensured timely delivery and quality outputs.
How to prepare for a job interview at Proclinical Staffing
✨Showcase Your Technical Expertise
As a Senior or Principal Statistical Programmer, it's crucial to demonstrate your technical skills in SAS programming. Be prepared to discuss specific projects where you've successfully implemented complex datasets and how you ensured high-quality outputs.
✨Understand Regulatory Guidelines
Familiarity with regulatory submissions is key for this role. Brush up on the latest guidelines and be ready to explain how you've applied them in past projects, particularly in relation to SDTM and ADaM standards.
✨Highlight Leadership Experience
This position involves leading programming projects and collaborating with various teams. Share examples of how you've led initiatives, mentored colleagues, or improved processes to ensure timely delivery of quality outputs.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world scenarios. Think about challenges you've faced in previous roles, particularly regarding dataset validation or quality control, and how you overcame them.