At a Glance
- Tasks: Lead the development of clinical data outputs and ensure quality for impactful studies.
- Company: Join CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Enjoy competitive salary, health benefits, and opportunities for professional growth.
- Other info: Be part of a diverse team that values inclusion and fosters innovation.
- Why this job: Make a real difference in patients' lives through innovative therapies and cutting-edge technology.
- Qualifications: 5+ years in clinical/statistical programming with SAS; strong teamwork and communication skills.
The predicted salary is between 60000 - 80000 £ 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, but not limited to: ADaM datasets, tables, figures, and listings output and/or QC of requested output, is the main focus of this role. This individual, working closely with the study statistician, will be responsible for review and acceptance of contract research organization (CRO) deliverables, which are mainly, but not limited to, datasets in submission-ready standard format (ADaM), tables, figures, and listings, and submission packages. This individual will participate 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. This individual will interface with other departments (e.g., Biostatistics, Data Management, Regulatory Operations, Medical Writing, ESP teams) to ensure Standard Operating Procedures are followed and the correct study data are used for all requests. This individual will participate 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 adhoc and study deliverables, including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content.
- Leads the production and validation efforts for the designed output; this may include 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 (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
- Supports the review of related deliverables when provided by CROs.
- Leads requested efforts for pooled and exploratory analyses, working closely with clinical programming team and their collection of legacy data.
- Leads the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures, and listings) 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 but not limited to:
- Support responses to regulatory agencies,
- Generate an integrated summary of safety and efficacy,
- Support publications and presentations,
- Support planning and reporting of clinical trials via exploratory analyses of available data,
- Replicate 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.
- Experiences with statistical programming using the SAS software, including development and use of SAS Macros.
- Knowledge in CDISC standards (CDASH, SDTM, ADaM).
- Ability to work effectively in a team setting, and to meet set 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.
Senior Programmer in Reading employer: CSL Behring
CSL Behring is an exceptional employer, offering a dynamic work environment in Waltham, MA, where innovation and collaboration thrive. Employees benefit from comprehensive support for their well-being, inclusive culture, and opportunities for professional growth within a global biotherapeutics leader dedicated to saving lives. With a focus on cutting-edge technologies and a commitment to diversity, CSL Behring empowers its team members to make a meaningful impact in the healthcare industry.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Programmer in Reading
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend meetups, and join relevant online forums. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by practising common questions and showcasing your technical skills. Make sure you can talk about your experience with SAS programming and CDISC standards confidently. We want to see you shine!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Check out our website for opportunities at StudySmarter and tailor your approach to fit what we’re all about.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. It shows your enthusiasm and professionalism, which we definitely appreciate.
We think you need these skills to ace Senior Programmer in Reading
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Senior Programmer role. Highlight your experience with SAS software and any relevant projects that showcase your skills in clinical programming and statistical analysis.
Showcase Your Teamwork Skills:Since this role involves collaboration with various departments, emphasise your ability to work effectively in a team. Share examples of how you've successfully collaborated with statisticians or other teams in past projects.
Be Clear and Concise:When writing your application, keep it straightforward and to the point. Use clear language to describe your qualifications and experiences, making it easy for us to see why you’re a great fit for the position.
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team!
How to prepare for a job interview at CSL Behring
✨Know Your SAS Inside Out
Make sure you brush up on your SAS programming skills, especially in relation to ADaM datasets and macros. Be prepared to discuss specific projects where you've used SAS to analyse clinical data, as this will show your hands-on experience.
✨Understand CDISC Standards
Familiarise yourself with CDISC standards like SDTM and ADaM. During the interview, be ready to explain how you've applied these standards in your previous roles, as this knowledge is crucial for the position.
✨Collaboration is Key
Since this role involves working closely with study statisticians and cross-functional teams, think of examples that demonstrate your teamwork skills. Highlight any experiences where you successfully collaborated on complex projects to meet tight deadlines.
✨Prepare for Technical Questions
Expect technical questions related to statistical programming and data analysis. Review common statistical concepts and be ready to solve problems on the spot. Practising with a friend or colleague can help you feel more confident.
