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Principal Statistical Programmer (FSP) Ukraine

Parexel International Corporation

Ukraine - Any Region - Home Based

The Principal Statistical Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors, and works independently to support various programing activities related to the analysis and reporting of clinical study data.

In addition, the Principal Statistical Programmer can fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required.

Further, the Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

What you’ll do:Act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Global Drug Development. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level.Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT).Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT.Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans.Provide and implement statistical programming solutions; ensure knowledge sharing.In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets.Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidanceAs assigned, act as subject matter expert (SME) or contribute to process improvement/non- clinical project initiatives with a focus on programming and analysis reporting procedures.QualificationsEducation BA/BS/MS or international equivalent experience in statistics,

(minimum/desirable): computer science, mathematics, life sciences or related field

Languages: Fluent English (oral and written).

Experience/Professional requirement:Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverablesAdvanced experience in contributing to statistical analysis plans and/or constructing technical programming specificationsGood knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programsGood understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures).Good communications and negotiation skills, ability to work well with others globallyExperience as Trial Programmer, including coordination of internal or external programmers on a given study/projectIdeally 5+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry

A little about us

Parexel is proud to be a leading Clinical Research Organization, with colleagues committed to make a difference. As a member of our global team, you’ll have discussions in an open environment—sharing expertise, promoting learning, and getting to know one another on a personal level. You’ll also experience supportive management that encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level statistical role, or into line management, Parexel prides itself on career opportunities for our employees.


2022-01-23 00:05:20


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