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: Competitive salary, equity options, and comprehensive health benefits.
- Other info: Dynamic, inclusive culture with opportunities for growth and collaboration across global teams.
- 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 30000 - 40000 £ 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 Maidenhead employer: CSL Behring
CSL Behring is an exceptional employer that prioritises innovation and employee growth within a collaborative and inclusive work culture. Located in Waltham, MA, employees benefit from competitive compensation, comprehensive well-being support, and the opportunity to contribute to life-saving therapies while working alongside a diverse team of professionals dedicated to making a difference in patients' lives.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Programmer in Maidenhead
✨Tip Number 1
Networking is key! Reach out to professionals in the industry, attend meetups or webinars, and connect with people on LinkedIn. You never know who might have a lead on your dream job!
✨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 and CDISC standards confidently.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Check out our website for openings that match your skills and interests!
✨Tip Number 4
Follow up after interviews! A simple thank-you email can leave a lasting impression and show your enthusiasm for the role. Plus, it keeps you on their radar!
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, ADaM datasets, and any relevant statistical programming skills. 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 skills can contribute to our team. Don't forget to mention your experience in clinical programming and your ability to work in cross-functional teams.
Showcase Your Problem-Solving Skills:In your application, give examples of how you've identified problems and developed solutions in your previous roles. We love candidates who can think critically and improve processes, so let us know how you've done this in the past!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us that you're serious about joining our team at StudySmarter!
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 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.
✨Collaborate and Communicate
Since this role involves working closely with study statisticians and cross-functional teams, think of examples that showcase your teamwork and communication skills. Highlight any experiences where you successfully collaborated on complex projects.
✨Prepare for Problem-Solving Questions
Expect questions that assess your analytical skills and problem-solving abilities. Prepare to discuss challenges you've faced in past projects and how you overcame them, particularly in relation to data quality and submission readiness.
