At a Glance
- Tasks: Lead the development of clinical study data and ensure high-quality deliverables.
- Company: Join CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on diversity and inclusion.
- Why this job: Make a real impact in healthcare by working with innovative therapies.
- Qualifications: 5+ years in clinical/statistical programming with SAS experience required.
The predicted salary is between 113000 - 134000 £ 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 Plasma
CSL Behring is an exceptional employer that prioritises innovation and employee growth, offering a collaborative work culture where your contributions directly impact patient lives. Located in Waltham, MA, employees benefit from competitive salaries, comprehensive benefits, and a commitment to inclusion and belonging, ensuring a supportive environment for all team members to thrive.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Programmer in Maidenhead
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We think you need these skills to ace Senior Programmer in Maidenhead
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show CSL Plasma that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at CSL Plasma.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that CSL Plasma does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at CSL Plasma
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at CSL Plasma. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
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Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at CSL Plasma. This shows your passion for the industry!
