Senior/Principal Clinical Programmer (SDTM)

Responsibilities

Leads a team of Programmers within Clinical Data Integration and Standards.Drives the development of programming standards to enable automated and controlled data flows and quality controlled datasets creation. Ensures access and version controlled filing of clinical data as well as archiving. Collaborates in the generation of an eCRF global library to ensure that collected data can be adequately mapped into standard datasets.Develops and implements a process for data integrations between systems utilized to support clinical studies.Leads and supports projects to implement the agreed Clinical Data Standards within Clinical Development. Oversees the management of the respective standards in the metadata repository of the Clinical Data Warehouse.Establishes the framework to ensure quality and accuracy – thus submission readiness – of clinical data as required by authorities (eg, SDTM, ADaM, define.xml).Develops and maintains departmental and cross functional Standard Operating Procedures and related QMS documents.Develops and conducts presentations and workshops to inform and educate stakeholders within Clinical Development on Clinical Data Standards & Programming related topics. Develops networks with external parties (key experts, contract research organizations) as pertains to Clinical Standards.Provides guidance on management of data storage and retrieval processes in a format that allows pooled analyses and exploration of legacy data. Collaborates with Global Biostatistics in the filing of datasets and related files for studies and submissions.Ensures provision of SAS programming to provide ready to analyze datasets in support of Biostatistics with clinical data analyses as required, including but not limited to quality oversight and consistency of clinical data, support of ongoing clinical trial evaluation, analyses for publications and regulatory submissions, health economic evaluations, explorative data analyses for planning of new trials.

Education

Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area with relevant experience.Other degrees and certifications considered, if commensurate with related data management/statistical programming experience.

Experience

Has considerable experience in statistical programming, within the CRO/pharmaceutical environment.Must have a comprehensive understanding of data management and/or statistical programming processes and standards as well as current regulatory requirements for data management and data standards for submission.Has knowledge of at least one widely used Clinical Data Management or Clinical Data Warehouse system.Knowledge in statistical programming using SAS.Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM) and experience in the implementation.Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing timelines.Experience in working in cross-functional, multi-cultural and international clinical trial teams.

Competencies

Excellent communication and analytical skills.Strong interpersonal and effective leadership skillsExcellent organizational skills and ability to prioritize individual and team workloadsAbility to work successfully in a matrix organizational structure.Is able to identify and engage internal and external expertise as neededProven networking skills and ability to share knowledge and experience amongst colleagues.Fluent in English, oral and in writing.al clinical trial teams.