Biostatistician II

Consulting, Inc.; Lisboa; Presencial; EUR 42 000 - 64 000; Tempo integral

Resumo da oferta

Consulting, Inc. in Lisbon seeks a Biostatistician to act as the primary statistical contact for internal and external project teams, supporting budget and timelines.

Responsibilities include CRF review, data cleaning input, development of IAPs and SAPs, SDTM/ADaM specifications, and TLF generation for analyses. Strong regulatory experience and the ability to explain statistics to non-technical colleagues are required.

Qualificações

• 2 years biostatistics experience in pharma or CRO.
• Master’s degree in Biostatistics or related field.
• CDISC SDTM/ADaM mapping experience.
• Knowledge of ICH guidelines relevant to biostatistics activities.
• Experience explaining complex statistical concepts to project teams.
• BLA/NDA submission experience; regulatory representation.

Responsabilidades

• Act as primary statistical contact for internal and external project team members.
• Communicate and work with Biostatistics management to maintain project budget and timelines.
• Review case report forms (CRFs) and completion instructions.
• Provide input to database design and data edit considerations for data collection/cleaning.
• Develop Interim Analysis Plans (IAPs) and SAPs per protocol.
• Develop SDTM/ADaM dataset specifications and TLFs for analysis.
• Perform statistical analysis by programming derived datasets and validating programs per SOPs.
• Develop/review statistical methods and results sections for reports and CSRs.
• Assist in planning and design of clinical studies, including randomization/blinding procedures, and protocol sections.

Conhecimentos

Statistical communication

Team collaboration

Regulatory submissions

Formação académica

Master’s degree in Biostatistics or related field

CDISC SDTM/ADaM mapping experience

Knowledge of ICH guidelines

Ferramentas

CDISC standards

Descrição da oferta de emprego

Responsibilities

• Act as primary statistical contact for internal and external project team members.
• Communicate and work with Biostatistics management tomaintainthe 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, orassistin the development of, Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol
• Develop program specifications – SDTM andADaMdataset specifications and mock tables,listingsand figures (TLFs) – needed to perform the analysis defined in the IAP/SAP
• Perform the statistical analysis by independently programming derived datasets and TLFs andvalidatethe developer’s corresponding programs per department SOPs
• Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications
• Assistin planning and designing clinical studies, including:
• randomizationandblindingproceduresdevelopment
• statistical methods section development in the protocol
• Develop,orassistin the developmentof,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 ensuretimely, standard, and quality deliverables to customers
• Maintainsaccuraterecords of all work performed andensureall relevantstatisticsdocuments are filed in the eTMF per the project-specific eTMF Plan
• Provide input to andparticipatein departmental meetings

Qualifications

• 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 andADaMdataset 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, autoimmunediseases, andkidney and liver disease