Principal Biostatistician , Medical Affairs (FSP -Permanent Homebased)
UK Visa Sponsorship Analytics
Analytics are greyed out due to low classification confidence (51.0%).
Occupation Type
Actuaries, economists and statisticians
Occupation Code Skill LevelHigher Skilled
Sponsorship Salary Threshold
£55,100
(£28.26 per hour)
Occupation rate applies
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Description
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.
Leadership
Key Responsibilities:
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
Leadership
Key Responsibilities:
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
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must
be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.