Assoc Dir, Biostatistics Rwe

Cti Clinical Trial And Consulting Services; Almada; On-site; EUR 80,000 - 134,000; Full time

Job summary

CTI Clinical Trial and Consulting Services is seeking a Senior Biostatistician to lead statistical activities across studies. You will act as the primary statistical contact, manage timelines, and guide CRF design, data management, and programming for analyses.

Requirements include 4+ years in biostatistics in pharma/CRO, a Master’s in Biostatistics, and CDISC/SDTM/ADaM experience. Regulatory submission experience is a plus, with opportunities in a global CRO setting.

Qualifications

• At least 4 years of related biostatistics experience in pharma or CRO environments.
• Master's degree in Biostatistics, Statistics, or related field.
• CDISC, SDTM, and ADaM dataset mapping experience.
• BLA/NDA submission experience; regulatory representation preferred.
• Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology and rare diseases preferred.
• Experience providing statistical consulting to internal/external clients.

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.
• Identify and communicate changes in scope to the clinical project manager and Biostatistics management.
• Review CRFs and completion instructions.
• Give input to database design and data edit considerations.
• Develop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs).
• Develop or review SDTM/ADaM specifications and TLFs for analyses.
• Perform statistical analyses and validate programs according to SOPs.
• Review programming of other team members.
• Develop or review statistical methods and results sections of reports and CSRs.
• Plan and design clinical studies including randomization/blinding procedures.
• Carry out activities per GCP/ICH guidelines.

Skills

Biostatistics experience

Statistical consulting

BLA/NDA submission experience

Education

Master's degree in Biostatistics

Tools

CDISC

SDTM

ADaM

Job description

Assist with the development and modification of department SOPs and work instructions

Assist with training new Biostatistics employees;
mentor and assistjunior 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 assistjunior 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 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.