Biostatistician II (Clinical Trial Experience Required)

CTI Clinical Trial and Consulting Services; Lisboa; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Tuition reimbursement

Paid parental leave

Health benefits

Job summary

CTI Clinical Trial and Consulting Services is seeking a Lead Biostatistician in Lisbon to manage statistical activities for complex studies. You will liaise with project teams, review data collection plans, and drive analysis plans in alignment with ICH, GCP, and CTI SOPs.

The role requires a Master’s in Biostatistics or related field, 2+ years of pharma/CRO biostatistics experience, and expertise in SDTM/ADaM mapping, study design, and regulatory submissions.

Qualifications

• 2 years of related biostatistics experience in pharmaceutical or CRO environment.
• Master’s degree in Biostatistics, Statistics, or related field.
• CDISC SDTM and ADaM dataset mapping experience.
• Knowledge of ICH guidelines and regulatory requirements as they relate to biostatistics activities.
• Experience explaining complex statistical concepts to project teams.
• BLA/NDA submission experience with regulatory interactions.
• Therapeutic experience in transplantation, autoimmune diseases, and kidney/liver disease.

Responsibilities

• Lead the Biostatistician on assigned studies and serve as primary statistical contact.
• Coordinate with Biostatistics management on project budgets and timelines.
• Review CRFs and data completion instructions.
• Contribute to database design and data cleaning considerations.
• Develop IAPs and SAPs as needed per protocol.
• Create SDTM/ADaM specifications and TLFs for analysis.
• Perform statistical analyses and validate programs per SOPs.
• Write/statistical methods for reports and CSRs.
• Assist in study design, power calculations, randomization plans, and protocol methods.
• Ensure compliance with GCP/ICH guidelines and CTI SOPs.
• Maintain accurate documentation in the eTMF per project plans.

Skills

Biostatistics experience

CDISC SDTM/ADaM mapping

ICH guidelines knowledge

Regulatory communication ability

BLA/NDA submission experience

Therapeutic experience (transplant/kid

Education

Master's degree in Biostatistics, Statistics, or related field

Job description

What You’ll Do:

• As the lead Biostatistician on the studies assigned, perform the following tasks:
• Act as primary statistical contact for internal and external project team members.
• Communicate and work with Biostatistics management to maintain the project budget and timelines.
• 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 assist in the development of, Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol
• Develop 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
• Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications
• Assist in planning and designing 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 assist in the development of, 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, and quality deliverables to customers
• Maintains accurate records of all work performed and ensure all relevant statistics documents are filed in the eTMF per the project-specific eTMF Plan

What You’ll Bring:

• 2 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
• Knowledge of ICH guidelines and regulatory requirements as they relate to biostatistics activities
• Experience providing ability to explain complex statistical concepts to other project team members
• BLA/NDA Submission experience; regulatory representation (i.e., meeting preparation/attendance, follow-up with regulatory communication)
• Therapeutic experience in transplantation, autoimmune diseases, and kidney and liver disease

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. For more information, visit www.ctifacts.com

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.

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