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- Tasks: Support clinical development with statistical analysis and programming using SAS.
- Company: Join Precision Medicine Group, a leader in biostatistics and clinical research.
- Benefits: Enjoy remote work flexibility and a collaborative team environment.
- Why this job: Make an impact in healthcare while working on innovative clinical trials.
- Qualifications: Master's or PhD in Statistics/Biostatistics with extensive experience required.
- Other info: Be part of a diverse team committed to equal opportunity and inclusion.
The predicted salary is between 36000 - 60000 £ per year.
Position Summary: Provides statistical support for all phases of clinical development. Specific responsibilities include writing and reviewing statistical sections of protocols, writing and reviewing statistical analysis plans including complex study designs, conducting statistical analyses and presenting results to project teams and sponsors, and developing SAS programs for tables, listings, figures and analysis datasets in accordance with Precision and/or sponsor procedures or study specific guidelines.
Essential functions of the job include but are not limited to:
- Develop and review statistical methods of the clinical study protocol including complex study designs
- Provide and/or verify sample size calculations.
- Perform or assist with advanced calculations including adaptive design
- Provide input into development of case report forms (CRFs)
- Author statistical analysis plans, including development of table, figure and listing shells, complex study design and late phase
- Review statistical analysis plans written by other biostatisticians
- Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
- Perform quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)
- Provide or supervise programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
- Ability to serve as a biostatistical consultant to company staff globally, with understanding of varying regional perspectives
- Review output across programs to ensure consistency.
- Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded biostatistician
- Review statistical sections of clinical study reports
- Work directly with sponsors, project managers, and external vendors on statistics-related project components
- Interact directly with study team
- Interact directly with sponsors
- Lead all statistical activities for study within timelines
- Independently perform budget health review on projects and review monthly invoices
- Perform oversight responsibilities on projects for other biostatisticians
- Assist with budget development and present at bid defense meetings
- Participate in the development and maintenance of departmental procedures and standards (templates, SOPs, WIs etc.)
- Review study tasks to ensure study being conducted in line with agreed budget; identify change in scope
- Other duties as assigned
Qualifications:
Minimum Required:
- Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience
Other Required:
- Experience with SAS
- Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Broad knowledge and superior understanding of advanced statistical concepts and techniques
Preferred:
- Experience with Oncology and rare diseases
- Broad experience with late phase and/or submissions
- Experience in consulting with clients on study design
- Superior understanding of a specific therapeutic area and/or statistical methodology (eg, adaptive design, missing data)
Skills:
- Mastery of statistical principles underlying clinical trials
- Mastery of SAS programming skills and familiarity with other packages
- Outstanding statistical skills
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
- Excellent problem-solving skills
- Excellent presentation skills
- Sound judgment/decision making
- Ability to establish and teach others to maintain effective working relationships with coworkers, managers and clients
- Service oriented, accountable and flexible
- Competency in written and spoken English
- Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures
- At all times to promote the image of Precision, acting as an ambassador to the Company
- Ensure that all internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports, etc.)
Principal Biostatistician Remote, United Kingdom employer: Precisionscientia
Contact Detail:
Precisionscientia Recruiting Team
QuestionForHR@precisionmedicinegrp.com
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Biostatistician Remote, United Kingdom
✨Tip Number 1
Familiarise yourself with the latest ICH guidelines and CDISC data structures. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the biostatistics community, especially those who have experience in oncology and rare diseases. Engaging in discussions can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of complex study designs you've worked on. Being able to articulate your experience with adaptive designs or sample size calculations will set you apart from other candidates.
✨Tip Number 4
Showcase your SAS programming skills by being ready to discuss any projects where you've developed analysis datasets or generated tables and figures. Highlighting your technical expertise is crucial for this role.
We think you need these skills to ace Principal Biostatistician Remote, United Kingdom
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in biostatistics, particularly in clinical trials. Emphasise your proficiency with SAS and any specific statistical methodologies you've used, especially those mentioned in the job description.
Craft a Strong Cover Letter: Write a cover letter that directly addresses the responsibilities outlined in the job description. Discuss your experience with statistical analysis plans and your ability to work with project teams and sponsors. Show enthusiasm for the role and the company.
Highlight Relevant Skills: In your application, clearly list your skills that align with the job requirements, such as mastery of statistical principles, SAS programming, and experience with late-phase studies. Use specific examples to demonstrate these skills.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Check for grammatical errors, clarity, and ensure that all information is accurate. A polished application reflects your attention to detail, which is crucial in this field.
How to prepare for a job interview at Precisionscientia
✨Showcase Your Statistical Expertise
Be prepared to discuss your mastery of statistical principles and advanced concepts. Highlight specific examples from your past experience where you successfully applied these skills in clinical trials, especially in complex study designs.
✨Demonstrate SAS Proficiency
Since SAS programming is crucial for this role, come ready to discuss your experience with SAS. You might even want to prepare a brief overview of a project where you developed SAS programs for analysis datasets or reports.
✨Understand Regulatory Standards
Familiarise yourself with industry standards such as ICH guidelines and FDA regulations. Be ready to explain how you've adhered to these standards in your previous roles, as this will show your commitment to compliance and quality.
✨Prepare for Team Collaboration Questions
This position requires interaction with various stakeholders, including sponsors and project managers. Think of examples that demonstrate your excellent communication and interpersonal skills, particularly in collaborative settings.
