Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Senior/Principal Biostatistician who shares our vision of providing clinical research excellence.
Joining Pivotal as a Senior/Principal Biostatistician means that you'll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation.
This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company.
You'll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.
Why Pivotal We are passionate and fully committed with medical science while using technology, to make a positive impact.
We provide an exceptional experience.
We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life.
We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong.
Your responsibilities will include: This position is responsible for leading the biostatistics component of projects across multiple studies or programs.
A Principal Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects.
Work as the assigned statistician on multiple studies or program studies, independently or as the lead statistician as required.
Coordinate the activities of other biostatistics/programming personnel on assigned projects to ensure timely completion of high-quality work.
Provides independent review of project work produced by other biostatisticians/statistical programmers in the department.
Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
Reviews annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high-quality database and the planned analysis.
Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.
May lead complex or multiple projects and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
Identifies out of scope tasks and escalates to management.
Provides statistical programming support as needed.
May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician.
May serve as a voting statistician on DSMBs and/or DMCs.
Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs, ensuring inspection readiness.
Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
Performs other work-related duties as assigned.
Minimal travel may be required.
Requirements: Graduate degree in biostatistics, maths or related discipline.
Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.
Proficiency in SAS programming and any other language (R; WinNonlin or similar).
Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
Knowledge and prior experience in handling CDISC standards (SDTM/ADaM files) and preparing final documentation for submission.
Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
Experience in interacting with regulatory agencies, as well as in regulatory submissions, is valued.
Prior experience with Bayesian methods and pharmacokinetic/pharmacodynamic statistical analysis will be highly regarded.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.
What you can expect: Resources that promote your career growth.
Leaders that support flexible work schedules.
Trainings to help you build your therapeutic knowledge.
Dynamic work environments that expose you to new experiences.
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