23 Principal Biostatistician Fsp jobs in the United Kingdom

**Who Are You?**
An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
**Sponsor-dedicated:**
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
**Position Overview:**
Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
**As a Principal Biostatistician, your responsibilities will include:**
+ Customer Segmentation & Targeting, Event Prediction, Propensity Modelling, Churn Modelling, Customer Lifetime Value Estimation, Forecasting, Recommender Systems, Marketing Mix Optimization, Price Optimization
+ Design, run and analyse A/B and multivariate hypothesis tests aimed at optimizing customer and patient experience. Also, pick up new skills and technologies necessary on the job. Articulate solutions/recommendations to business users. Works with senior data science team member to present analytical content concisely and effectively
+ Develop automation for repeatedly refreshing analysis and generating insights Collaborate with globally dispersed internal stakeholders and cross-functional teams to solve critical business problems and deliver successfully on high visibility strategic initiatives
+ Project manage own tasks and works with allied team members; plans proactively, anticipates and actively manages change, sets stakeholder expectations as required Independently identifies research articles and reproduce/apply methodology to business problems
**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**
+ Master's degree in statistics or a related discipline. Ph.D. strongly desired.
+ 9+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
+ Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership.
+ Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviours
+ SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
+ Knowledge of R programming (R Shiny/Python)
#LI-KO1
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

**Who Are You?**
An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods. In your career you have been taking responsibility for statistical matters both at the trial and the project level, and are willing to use that experience to drive best practices at our FSP client's drug development organization. You are enthusiastic, motivated to do great work and collaborate easily with various functions at the client. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
**Sponsor-dedicated:**
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's safety standards and innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
**Position Overview:**
You will be part of a small but select team at our client which oversees statistical and technical aspects of safety evaluation in drug development. You will work on standards for evaluating safety, including document templates, process related matters and methodological standards and innovation. It is possible that you will also be directly involved in project safety matters.
**As a Principal Biostatistician for Safety Standards, your responsibilities will include:**
+ Drive or contribute to the client's safety standards, e.g. with respect to e.g. developing templates for planning and reporting, operational standards, providing input with respect to technologies, applications, standard reporting tools, processes etc.
+ May participate in statistical innovation initiatives with respect to evaluation and reporting safety, including new methodologies and technologies, visualization etc.
+ Works with various stakeholders in different functions; participates in and potentially leads cross-functional workstreams and initiatives.
+ May interact directly with specific project teams in order to help improve their planning and reporting with respect to safety.
+ Project manage own tasks and works with allied team members; plans proactively, anticipates and actively manages change, sets stakeholder expectations as required Independently identifies research articles and reproduce/apply methodology to business problems
**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**
+ Master's degree in statistics or a closely related discipline. Ph.D. is desirable.
+ 9+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
+ Experience with key safety related activities in drug development, including regulatory submission/ISS, periodic safety reporting, Data Monitoring Committees, Health Authority interactions etc. Strong awareness of regulatory guidelines including ICH and GCP, and experience with CDISC standards.
+ Strong methodological skills and an innovation mindset are desirable, as is experience with novel approaches to evaluating safety.
+ Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership.
+ Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviours
+ Knowledge of SAS is expected; Knowledge of R programming, Python and other tools are strongly desired.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

**Who Are You?**
An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead **late phase** **Oncology** clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
**Sponsor-dedicated:**
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
**Position Overview:**
Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
**As a Principal Biostatistician, your responsibilities will include:**
- Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.
- Needs to be experienced in **Oncology** (preferred in hematology and late phase) and expected to have prior experience of working on a registrational study, playing an independent statistician role, sitting in study team meetings and discussing with the team on statistical analysis plan, design of outputs, addressing health authority questions
- Lead statistical teams on clinical development projects, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project.
- Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
- Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
- Needs familiarity with ADAM and SDTM and can do hands-on work (e.g., derive outputs or summary statistics) to address team's questions quickly
- When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
- Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
- Contribute to the development of sourcing strategy for projects.
- Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**
**Qualifications and Experience:**
- Minimum Education: Ph.D. or MS in Statistics, Biostatistics or related discipline.
- Minimum Work Requirements:
o At least 6 years of experience as biostatistician in the Pharmaceutical/Biotechnology industry in clinical development.
o At least 3 years of experience as a Lead Biostatistician for clinical development projects.
o Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data e-submission to FDA.
o Fluent in English (French or German is a plus).
o Working SAS & CDISC knowledge.
o Experience in R is a plus.
**Skills:**
o Works effectively in international teams, effectively operates within a matrix organization and with multi-disciplinary groups.
o Understands and anticipates customer needs and responds to their inquiries.
o Verbal and written communication is effective with multi-disciplinary groups.
o Work is well-organized, of high-quality, meeting timelines. Able to balance concurrent tasks and responsibilities.
o Excellent time management.
o Brings creative ideas and makes suggestions for optimization.
o Exhibits leadership for the biostatistics team working on the same clinical development teams.
o Exhibits the ability to mentor and develop statistical colleagues.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

**Who Are You?**
An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead **late phase** **Oncology** clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
**Sponsor-dedicated:**
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
**Position Overview:**
Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
**As a Principal Biostatistician, your responsibilities will include:**
- Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.
- Needs to be experienced in **Oncology** (preferred in hematology and late phase) and expected to have prior experience of working on a registrational study, playing an independent statistician role, sitting in study team meetings and discussing with the team on statistical analysis plan, design of outputs, addressing health authority questions
- Lead statistical teams on clinical development projects, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project.
- Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
- Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
- Needs familiarity with ADAM and SDTM and can do hands-on work (e.g., derive outputs or summary statistics) to address team's questions quickly
- When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
- Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
- Contribute to the development of sourcing strategy for projects.
- Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**
**Qualifications and Experience:**
- Minimum Education: Ph.D. or MS in Statistics, Biostatistics or related discipline.
- Minimum Work Requirements:
o At least 6 years of experience as biostatistician in the Pharmaceutical/Biotechnology industry in clinical development.
o At least 3 years of experience as a Lead Biostatistician for clinical development projects.
o Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data e-submission to FDA.
o Fluent in English (French or German is a plus).
o Working SAS & CDISC knowledge.
o Experience in R is a plus.
**Skills:**
o Works effectively in international teams, effectively operates within a matrix organization and with multi-disciplinary groups.
o Understands and anticipates customer needs and responds to their inquiries.
o Verbal and written communication is effective with multi-disciplinary groups.
o Work is well-organized, of high-quality, meeting timelines. Able to balance concurrent tasks and responsibilities.
o Excellent time management.
o Brings creative ideas and makes suggestions for optimization.
o Exhibits leadership for the biostatistics team working on the same clinical development teams.
o Exhibits the ability to mentor and develop statistical colleagues.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

**Job Overview:**
As a Principal Biostatistician you will liaise with cross-functional teams, to drive the quality statistical planning, analysis and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials. Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries.
**Key** **Responsibilities:**
**Leadership:**
Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company
Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee
Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication
Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or NDA sections
Leading studies at an operational level
Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures
Consult on operational/statistical/therapeutic area topics
**Knowledge Sharing:**
Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses
Performs as subject matter expert (SME)
**Risk Management:**
Identifies risks to project delivery and/or quality, leads in a way to minimize risks
Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions
**Lock and Unblinding Process:**
Leads the database lock and unblinding process for the statistical team
Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules)
**Statistical Expertise:**
Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports)
Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data)
Provide expert review of ADaM reviewers guide (ADRG) and metadata
Perform senior biostatistical review (SBR)
Produce or perform quality control review of sample size calculations for complex studies
**Requirements:**
+ Masters or PhD degree in Biostatistics or a related field with relevant experience within the life-science industry
+ Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials
+ Expert in strategically collaborating with clinical and drug development experts
+ Experience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries
+ In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
+ Strong working knowledge of SAS or R
+ Excellent knowledge of CDISC Data Standards
+ Superb communication and collaboration skills
+ Independent and pro-active problem solving skills
+ Rare disease and immunology experience is greatly preferred.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

Our client is offering an exciting Graduate Trainee opportunity in Data Analysis, based remotely. This program is designed for ambitious individuals who have recently graduated and are keen to build a career in the data science field. As a Graduate Trainee, you will gain hands-on experience in collecting, cleaning, analyzing, and interpreting large datasets to identify trends and insights. You will work closely with experienced data analysts and scientists, contributing to real-world projects that drive business decisions. Responsibilities include developing data models, creating visualizations, and presenting findings to stakeholders. The ideal candidate will possess a strong analytical mindset, excellent problem-solving abilities, and a foundational understanding of statistical concepts. Proficiency in at least one programming language commonly used in data analysis (e.g., Python, R) and familiarity with SQL are highly desirable. Experience with data visualization tools (e.g., Tableau, Power BI) would be a significant advantage. You should be eager to learn, adaptable, and capable of working effectively in a remote team environment. A Bachelor's or Master's degree in a quantitative field such as Statistics, Mathematics, Computer Science, Economics, or a related discipline is required. This is a fantastic opportunity to kickstart your career in a rapidly growing industry.
Key Responsibilities:

• Assist in data collection, cleaning, and preprocessing.
• Perform data analysis to identify trends and patterns.
• Develop data visualizations and reports.
• Support senior analysts in deriving insights from data.
• Collaborate with team members on data-driven projects.
• Learn and apply new data analysis techniques and tools.

A forward-thinking technology company is offering an exciting Graduate Trainee position focused on Data Analysis, based in the Brighton, East Sussex, UK area, with a fully remote working arrangement. This internship provides a unique opportunity for recent graduates to gain hands-on experience in data analytics, machine learning, and business intelligence within a dynamic and supportive environment. The Graduate Trainee will work closely with senior data scientists and analysts to collect, clean, and analyze large datasets, identify trends, and develop insights to inform business decisions. Responsibilities include assisting in the development of data models, creating reports and dashboards using visualization tools, and contributing to the implementation of data-driven strategies. You will have the opportunity to learn and apply various analytical techniques and tools, such as SQL, Python, R, and Tableau. The ideal candidate will be a recent graduate with a degree in a quantitative field such as Computer Science, Statistics, Mathematics, Economics, or a related discipline. Strong analytical and problem-solving skills are essential, along with a keen attention to detail. Familiarity with programming languages like Python or R is highly desirable. Excellent communication skills and the ability to work collaboratively in a remote team setting are crucial. Enthusiasm for data and a willingness to learn are key attributes we are looking for. This role is designed to provide a comprehensive learning experience and a potential pathway to a full-time career in data science. You will gain valuable practical experience and mentorship to build a strong foundation in the field. This is a fully remote role, allowing you to contribute effectively from your preferred location.

Our client is offering an exceptional Graduate Trainee position focused on Data Analysis, based in **Sunderland, Tyne and Wear**. This is an excellent opportunity for a recent graduate eager to build a career in data science and analytics. You will receive comprehensive training and mentorship, working alongside experienced professionals on real-world projects. The role involves learning to collect, clean, analyze, and interpret complex datasets to provide actionable insights. You will gain hands-on experience with various data analysis tools and techniques, contributing to key business decisions. This role is primarily office-based, fostering direct collaboration and learning within the team.

Key Responsibilities:

• Assist in the collection, cleaning, and organization of data from various sources.
• Perform data analysis using statistical methods and software.
• Develop reports and visualizations to communicate findings effectively.
• Support senior analysts in identifying trends and patterns within datasets.
• Learn and apply data modeling techniques.
• Participate in team meetings and contribute to project discussions.
• Maintain data integrity and accuracy.
• Develop skills in programming languages commonly used in data analysis (e.g., Python, R, SQL).

Qualifications:

• A recent graduate with a degree in Mathematics, Statistics, Computer Science, Economics, or a related quantitative field.
• Strong analytical and problem-solving skills.
• Proficiency in Microsoft Excel; experience with other data analysis tools is a plus.
• Eagerness to learn and develop skills in data analysis and programming.
• Good communication and teamwork abilities.
• Attention to detail and commitment to accuracy.
• Must be eligible to work in the UK.

This entry-level position provides a structured pathway for career advancement within a supportive and growth-oriented environment. Join our client and kick-start your career in the exciting field of data analysis.

CK Group are recruiting for a Data Analysis and Validation Associate to join a global animal health company on a contract basis for 12 months.



Salary:

147.90 per day PAYE



Data Analysis and Validation Associate role:

• Responsible for data analysis, entry and Validation related activities across the Pirbright manufacturing facility, to enable the large scale production of FMD and BTV antigen and finished product in a timely and cost effective manner.
• Analyse production data to identify trends, deviations, and performance metrics.
• Assist in the execution of cleaning validation protocols in line with GMP requirements.
• Bring in SQL / Power BI approaches to improve the site approach to data.
• Support sampling, documentation, and coordination of validation activities.

Your Background :

• GMP experience is essential
• Have a scientific or engineering discipline degree (e.g., Biochemistry, Biotechnology, Chemical Engineering, Pharmaceutical Sciences).
• Understanding of cleaning validation principles and documentation practices.
• Experience with data handling and analytics
• Knowledge of HSE, bio-safety standards, GMP regulations as well as main tools and principles of operational excellence

Company:

Our client is a leading manufacturer of vaccines, parasiticides and pharmaceuticals to protect animals. They are also one of the fastest growing animal health companies in the UK.



Location:

This role is based at our clients site near Pirbright.



Apply:

For more information, or to apply for this Data Analysis and Validation Associate role, please contact the Key Accounts Team on (phone number removed) or email (url removed). Please quote reference (Apply online only).



It is essential that applicants hold entitlement to work in the UK



Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.



INDKA