Sr Biostatistician

CTI Clinical Trial and Consulting Services; Lisboa; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Hybrid work from home

Health benefits

Tuition reimbursement

Job summary

CTI Clinical Trial and Consulting Services seeks an experienced Biostatistician to lead statistical activities on multiple studies. You will act as primary statistical contact, oversee analysis plans, and supervise programming of derived datasets and TLFs per GCP/ICH guidelines.

You will design studies, review CSR sections, and mentor junior statisticians. A Master’s in Biostatistics and 4+ years of experience are required; CTI offers hybrid work and strong career growth.

Qualifications

• 4+ years of biostatistics experience in pharma or CRO environment.
• Experience providing statistical consulting to internal/external clients.
• CDISC, SDTM, and ADaM mapping experience.

Responsibilities

• Act as primary statistical contact for internal and external project team members.
• Manage projects to ensure statistics tasks are performed within the entire project timeline.
• Proactively identify and communicate changes in scope to the clinical project manager and Biostatistics management.
• Review case report forms (CRFs) and completion instructions.
• Develop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs).
• Develop or review SDTM and ADaM dataset specifications and mock tables, listings, and figures (TLFs).
• Perform the statistical analysis by programming derived datasets and TLFs and validating programs.
• Review programming of other team members.
• Develop or review statistical methods and results sections of reports or CSR.
• Plan and design clinical studies, including overall design, endpoints, power analysis, and randomization procedures.

Skills

Biostatistics experience

Statistical consulting

Mentoring and training

Education

Master’s degree in Biostatistics or related field

Tools

CDISC SDTM ADaM mapping

BLA/NDA submission experience

Job description

• Assist with the development and modification of department SOPs and work instructions
• Assist with training new Biostatistics employees; mentor and assist junior level Biostatisticians
• Develop study bids and changes in scope for Biostatistics tasks in response to prospective client’s request for proposals (RFPs)
• Attend and present the Biostatistics study execution tasks at capabilities presentations.
• As the lead Biostatistician on the studies to which you are assigned, perform, or oversee the following tasks:
• Act as primary statistical contact for internal and external project team members
• Manage projects to ensure statistics tasks are performed within the entire project timeline. Keep Biostatistics management aware of changes to project timelines
• Proactively identify and communicate changes in scope to the clinical project manager and Biostatistics management
• Review case report forms (CRFs) and completion instructions
• Give input to database design and data edit considerations necessary to collect and clean data
• Develop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol
• Develop or review program specifications – SDTM and ADaM dataset specifications and mock tables, listings, and figures (TLFs) – needed to perform the analysis defined in the IAP/SAP
• Perform the statistical analysis by independently programming derived datasets and TLFs and validate the developer’s corresponding programs per department SOPs
• Review programming of other team members
• Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications
• Plan and design clinical studies, including:
• randomization and blinding procedures development
• statistical methods section development in the protocol
• Develop or review Randomization Plans, and randomization programs or lists
• Carry out all activities according to CTI SOPs and project-specific conventions within the framework of Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines
• Rely on instructions and Biostatistics SOPs to ensure timely, standard, quality deliverables to customers
• Maintain accurate records of all work performed and ensure all relevant statistics documents are filed in the eTMF per the project-specific eTMF Plan
• Provide input to and participate in departmental meetings

What You'll Do

• Assist with the development and modification of department SOPs and work instructions
• Assist with training new Biostatistics employees; mentor and assist junior level Biostatisticians
• Develop study bids and changes in scope for Biostatistics tasks in response to prospective client’s request for proposals (RFPs)
• Attend and present the Biostatistics study execution tasks at capabilities presentations.
• As the lead Biostatistician on the studies to which you are assigned, perform, or oversee the following tasks:
• Act as primary statistical contact for internal and external project team members
• Manage projects to ensure statistics tasks are performed within the entire project timeline. Keep Biostatistics management aware of changes to project timelines
• Proactively identify and communicate changes in scope to the clinical project manager and Biostatistics management
• Review case report forms (CRFs) and completion instructions
• Give input to database design and data edit considerations necessary to collect and clean data
• Develop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol
• Develop or review program specifications – SDTM and ADaM dataset specifications and mock tables, listings, and figures (TLFs) – needed to perform the analysis defined in the IAP/SAP
• Perform the statistical analysis by independently programming derived datasets and TLFs and validate the developer’s corresponding programs per department SOPs
• Review programming of other team members
• Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications
• Plan and design clinical studies, including:
• overall study design development
• outcome / endpoint determination
• power analysis / sample size estimation reports
• randomization and blinding procedures development
• statistical methods section development in the protocol
• Develop or review Randomization Plans, and randomization programs or lists
• Carry out all activities according to CTI SOPs and project-specific conventions within the framework of Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines
• Rely on instructions and Biostatistics SOPs to ensure timely, standard, quality deliverables to customers
• Maintain accurate records of all work performed and ensure all relevant statistics documents are filed in the eTMF per the project-specific eTMF Plan
• Provide input to and participate in departmental meetings

What You'll Bring

• At least 4 years of related biostatistics experience in either a pharmaceutical or CRO environment or other relatable statistical experience
• Master’s degree in Biostatistics, Statistics, or related field
• CDISC, SDTM, and ADaM dataset mapping experience
• BLA/NDA Submission experience; regulatory representation (i.e., meeting preparation/attendance, follow-up with regulatory communication) preferred
• Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology and rare disease preferred
• Experience providing statistical consulting to internal/external clients preferred

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note

In light of recent increase in hiring scams, if you’re selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process