At a Glance
- Tasks: Lead clinical programming projects and ensure high-quality data deliverables.
- Company: Join a leading pharmaceutical company focused on innovative healthcare solutions.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Collaborative environment with diverse teams and global reach.
- Why this job: Make a real impact in clinical trials and improve patient outcomes.
- Qualifications: 5+ years in clinical/statistical programming with SAS experience.
The predicted salary is between 115000 - 135000 £ per year.
The Senior Statistical Programmer is responsible for providing hands-on support and technical guidance on clinical study teams. The development of study and ad-hoc output, including ADaM datasets, tables, figures, and listings output and/or QC of requested output, is the main focus of this role. This individual works closely with the study statistician and is responsible for review and acceptance of contract research organization (CRO) deliverables, which are mainly datasets in submission-ready standard format (ADaM), tables, figures, listings, and submission packages. The role includes participation in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for all requested analyses. The individual interfaces with other departments (e.g., Biostatistics, Data Management, Regulatory Operations, Medical Writing, ESP teams) to ensure SOPs are followed and the correct study data are used for all requests. The Senior Statistical Programmer also participates in department and cross-functional technology development and process improvement initiatives.
Main Responsibilities and Accountabilities
- Collaborates with the study statistician to design data structure and specifications for ad-hoc and study deliverables.
- Leads the production and validation efforts for the designed output, including oversight of work by CROs.
- Collaborates with peers and statisticians to ensure the quality and accuracy – thus submission readiness – of clinical data as required by authorities.
- Supports the review of related deliverables when provided by CROs.
- Leads requested efforts for pooled and exploratory analyses, working closely with the clinical programming team.
- Leads the in-house specification and delivery of ISS and ISE datasets and associated output when not provided by CRO.
- Leads the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
- Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
- Works closely with clinical study teams to ensure that project timelines are met with high-quality deliverables.
Additional Tasks
- Supports CR&D staff in data analysis requests.
- Performs additional statistical analyses, including support responses to regulatory agencies, generating integrated summary of safety and efficacy, supporting publications and presentations, and supporting planning and reporting of clinical trials via exploratory analyses of available data.
- Replicates CRO and CSL statistician analyses for QC.
Job Qualifications and Experience Requirements
Education
- BSc in Computer Science, Mathematics, Statistics or related area with relevant experience. Other degrees and certifications considered if commensurate with related programming experience.
Experience
- At least 5 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
- Understanding of clinical programming and/or statistical programming processes and standards.
- Experience with statistical programming using SAS software, including development and use of SAS Macros.
- Knowledge of CDISC standards (CDASH, SDTM, ADaM).
- Ability to work effectively in a team setting and meet goals by managing own timelines.
- Ability to work in cross-functional, multicultural, and international clinical trial teams.
Competencies
- Good communication and analytical skills.
- Good planning and organizational skills.
- Ability to work successfully in a matrix organizational structure.
- Networking skills and ability to share knowledge and experience amongst colleagues.
- Fluent in English, oral and in writing.
Compensation
The expected base salary range for this position at hiring is $143,000 - $169,000 USD for the Waltham, MA USA location. Individual base salary is determined by qualifications, skill level, experience, competencies and other relevant factors.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit the accessibility statement.
Senior Programmer in Maidenhead employer: CSL Plasma Inc.
At CSL, we pride ourselves on being an exceptional employer, offering a collaborative and innovative work culture that empowers our employees to thrive. Located in Waltham, MA, our team enjoys competitive compensation, comprehensive benefits, and ample opportunities for professional growth within the dynamic field of clinical programming. Join us to make a meaningful impact in the healthcare sector while working alongside talented professionals dedicated to excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Programmer in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend meetups, and join online forums. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by practising common questions and showcasing your technical skills. We recommend doing mock interviews with friends or using online platforms to get comfortable with the process.
✨Tip Number 3
Showcase your projects! Whether it's through a portfolio or GitHub, having tangible examples of your work can set you apart. Make sure to highlight any SAS programming or clinical data analysis you've done.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Senior Programmer in Maidenhead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Programmer role. Highlight your experience with SAS software and any relevant projects you've worked on, especially those involving clinical data. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background in statistical programming makes you a great fit. Don’t forget to mention your teamwork skills and how you’ve collaborated with others in the past.
Showcase Your Technical Skills:Since this role involves a lot of technical work, be sure to highlight your proficiency in SAS and any experience with CDISC standards. We love seeing specific examples of how you've used these skills in previous roles, so don’t hold back!
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to upload all your documents in one go. Plus, it helps us keep track of your application better!
How to prepare for a job interview at CSL Plasma Inc.
✨Know Your SAS Inside Out
Make sure you brush up on your SAS programming skills, especially around ADaM datasets and macros. Be ready to discuss specific projects where you've used SAS to analyse clinical data, as this will show your hands-on experience.
✨Understand the Clinical Landscape
Familiarise yourself with the clinical trial process and the role of statistical programming within it. Being able to speak knowledgeably about how your work impacts study outcomes will impress the interviewers.
✨Collaboration is Key
Prepare examples of how you've successfully collaborated with cross-functional teams in the past. Highlight your communication skills and how you’ve ensured quality and accuracy in deliverables, as teamwork is crucial in this role.
✨Showcase Problem-Solving Skills
Think of instances where you've identified issues in programming or data analysis and how you resolved them. This will demonstrate your analytical skills and ability to improve processes, which is a big part of the job.
