At a Glance
- Tasks: Lead statistical strategies for clinical trials and regulatory submissions in a dynamic environment.
- Company: Join CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative culture with a focus on innovation and career advancement.
- Why this job: Make a real impact in healthcare by innovating therapies for patients worldwide.
- Qualifications: PhD or MS with extensive experience in drug development and statistical leadership.
The predicted salary is between 80000 - 100000 £ per year.
The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program.
Main Responsibilities:
- Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
- Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews.
- Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
- Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
- Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
- Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA).
- Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
- Manage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP.
- Support or lead improvement initiatives within the department, organization and/or pharma industry.
- Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.
Education and Experience:
- PhD with 8 years of experience or MS with 11 years of experience in drug development.
- Experience providing statistical leadership at compound/indication level.
- Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy.
- Solid experience in applications of advanced statistical methodologies.
- Leading roles in regulatory submissions.
- Experience in interactions with major regulatory authorities preferred.
- Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred.
- Track record of innovation preferred.
Competencies:
- Familiarity with regulatory guidance and interactions - Broad knowledge of clinical development and processes.
- Ability to collaboratively work and provide leadership in matrix environment - Strong interpersonal and communication skills (verbal and written in English).
- Good working knowledge of SAS and/or R.
- Expertise in a range of statistical methodologies.
- Demonstrated use of innovative / creative methodology for analysis of clinical data.
- Familiarity with relevant regulatory guidance documents.
Expertise in:
- CDISC, statistical programming, and/or data standards.
- Biostatistics and Statistical Programming Operations.
About CSL Behring: CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
Associate Director, Biostatistics (2) in Thatcham employer: CSL Plasma Inc.
CSL Seqirus is an exceptional employer, offering a dynamic work environment where innovation and collaboration thrive. As the Head of Global Labelling, you will lead a talented team dedicated to ensuring the highest standards in labelling for life-saving vaccines, while benefiting from a culture that prioritises employee growth and development. Located in a vibrant area, CSL Seqirus provides unique opportunities for professional advancement and a commitment to making a meaningful impact on global health.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Biostatistics (2) in Thatcham
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We think you need these skills to ace Associate Director, Biostatistics (2) in Thatcham
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 Inc. 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 Inc..
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 Inc. 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 Inc.
✨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 Inc.. 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.
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