Principal Biostatistician

Principal Biostatistician

Full-Time 48000 - 72000 £ / year (est.) Home office (partial)
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At a Glance

  • Tasks: Lead statistical support for clinical trials, from protocol writing to data analysis.
  • Company: Join Precision Medicine Group, a leader in innovative healthcare solutions.
  • Benefits: Enjoy flexible working options and a collaborative, inclusive culture.
  • Why this job: Make a real impact in healthcare while developing your statistical expertise.
  • Qualifications: Master's or PhD in Statistics/Biostatistics with extensive experience required.
  • Other info: Be part of a diverse team committed to advancing medical research.

The predicted salary is between 48000 - 72000 £ per year.

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 (e.g., 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 employer: Precision For Medicine

At Precision Medicine Group, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our Principal Biostatisticians benefit from comprehensive professional development opportunities, competitive compensation, and the chance to work on cutting-edge clinical trials in a supportive environment. Located in the United Kingdom, our team enjoys a vibrant atmosphere that encourages growth, creativity, and meaningful contributions to the field of medicine.
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Contact Detail:

Precision For Medicine Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Principal Biostatistician

✨Tip Number 1

Network with professionals in the biostatistics field, especially those who have experience in clinical trials. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in biostatistics.

✨Tip Number 2

Familiarise yourself with the specific statistical software mentioned in the job description, particularly SAS. Consider taking online courses or certifications to enhance your skills and demonstrate your proficiency during interviews.

✨Tip Number 3

Prepare to discuss your experience with complex study designs and statistical analysis plans in detail. Be ready to provide examples of how you've contributed to previous projects, particularly in late-phase studies or oncology.

✨Tip Number 4

Research the company’s recent projects and publications to understand their focus areas and methodologies. This knowledge will help you tailor your discussions and show your genuine interest in their work during the interview process.

We think you need these skills to ace Principal Biostatistician

Master's degree or equivalent in Statistics, Biostatistics, or related field
PhD degree in Statistics, Biostatistics, or related field (preferred)
10+ years experience in biostatistics or related field
7+ years experience with a PhD
Expertise in SAS programming
Knowledge of ICH guidelines and CDISC data structures
Understanding of 21 CFR Part 11 and FDA guidelines
Advanced statistical concepts and techniques
Experience with late phase clinical trials
Consulting experience on study design
Excellent organisational skills
Time management skills
Strong communication and interpersonal skills
Problem-solving skills
Presentation skills
Ability to establish effective working relationships
Service-oriented and accountable
Competency in written and spoken English
Ability to train others on applicable regulations
Familiarity with oncology and rare diseases (preferred)

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience in biostatistics, particularly any work with clinical trials and SAS programming. Use keywords from the job description to demonstrate your fit for the role.

Craft a Strong Cover Letter: In your cover letter, explain why you are passionate about biostatistics and how your background aligns with the responsibilities outlined in the job description. Mention specific projects or experiences that showcase your skills.

Highlight Technical Skills: Clearly outline your proficiency in SAS and any other statistical software you are familiar with. Include examples of how you've used these tools in past roles to support clinical development.

Showcase Communication Skills: Since the role involves presenting results and collaborating with project teams, emphasise your communication and interpersonal skills. Provide examples of how you've effectively communicated complex statistical concepts to non-statistical audiences.

How to prepare for a job interview at Precision For Medicine

✨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.

✨Demonstrate SAS Proficiency

Since SAS programming is crucial for this role, be ready to talk about your experience with SAS. You might even want to prepare a brief overview of a project where you used SAS to generate analysis datasets or reports.

✨Understand Regulatory Standards

Familiarise yourself with industry standards such as ICH guidelines and FDA regulations. Be prepared to discuss how you've ensured compliance in previous roles, as this will show your understanding of the regulatory landscape.

✨Prepare for Scenario-Based Questions

Expect scenario-based questions that assess your problem-solving skills and ability to handle complex study designs. Think of specific challenges you've faced in past projects and how you overcame them, as this will demonstrate your critical thinking abilities.

Principal Biostatistician
Precision For Medicine
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