At a Glance
- Tasks: Lead the development and validation of clinical study data outputs using SAS.
- Company: Join CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Enjoy competitive salary, equity options, and comprehensive health benefits.
- Other info: Be part of a diverse team that values inclusion and innovation.
- Why this job: Make a real impact in healthcare by working on innovative therapies.
- Qualifications: 5+ years in clinical/statistical programming with SAS; strong teamwork skills required.
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 employer: CSL Behring
CSL Behring is an exceptional employer that prioritises innovation and employee growth, offering a collaborative work culture where diversity and inclusion are celebrated. Located in Waltham, MA, employees benefit from access to cutting-edge technologies and the opportunity to contribute to life-saving therapies, while enjoying comprehensive benefits that support their well-being and professional development.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Programmer
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend meetups, and join online forums. The more people you know, the better your chances of landing that Senior Programmer role.
✨Tip Number 2
Show off your skills! Create a portfolio showcasing your SAS programming projects and any relevant analyses you've done. This will give potential employers a taste of what you can bring to the table.
✨Tip Number 3
Prepare for interviews by brushing up on common technical questions related to clinical programming and CDISC standards. Practice explaining your past projects and how they relate to the job description.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're genuinely interested in joining our team at CSL Behring.
We think you need these skills to ace Senior Programmer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Programmer role. Highlight your experience with SAS, ADaM datasets, and any relevant projects that showcase your skills in clinical programming. We want to see how your background aligns with 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 experience makes you a perfect fit. Don’t forget to mention your collaborative spirit and how you’ve worked with cross-functional teams before.
Showcase Your Technical Skills:Since this role involves a lot of technical work, make 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 past 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 keep track of your application status. Plus, we love seeing candidates who take the initiative to connect with us directly!
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 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 CDISC Standards
Familiarise yourself with CDISC standards like SDTM and ADaM. During the interview, be prepared to explain how you've applied these standards in your previous roles, as this knowledge is crucial for the position.
✨Collaboration is Key
This role involves working closely with various teams, so highlight your teamwork skills. Share examples of how you've successfully collaborated with statisticians or CROs to deliver high-quality outputs on time.
✨Prepare for Technical Questions
Expect technical questions related to statistical programming and data analysis. Practice explaining complex concepts in a simple way, as this will demonstrate your communication skills and ability to work in cross-functional teams.
