Company Description

Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia

Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Descriptio

nThe Senior Statistical Programmer (SP) within the Ergomed Biostatistics (BS) department is responsible for the creation of SDTM/ADaM datasets and programming tables, listings and figures or other types of output, supporting and complimenting the biostatistician(s) of a project and creating and maintaining appropriate documentation. The Senior Statistical Programmer is accountable for the first-time quality of the product, either dataset or output, via thorough QC steps

.
Role and Responsibiliti

• esMaintains responsibility for all assigned duties within a clinical study, this may includ
• e:Ensuring that work is performed on ti
• meEnsuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quali
• tyWorks with other biometrics’ team members to represent the needs and input of the programming components of the stu
• dyProgram SDTM and ADaM datase
• tsCreate SDTM and ADaM specificatio
• nsCreate CDISC submission packages e.g. Define.xml and Reviewers Gui
• deProgram tables, listings, and figures in SAS from specificatio
• nsDeliver training and mentorship to SP and other operational staff, as applicab
• leContribute to the development of the department in supporting adherence to good programming and best practices by contributing to training, development of macros and standard processes, input and/or review of controlled documents, or other related conte
• ntAct as a statistical programming expert and provide consultative support to internal programmers and biostatisticians with any programming related topi
• csAct as a program or sponsor lead across multiple studies, clinical programs, and/or large complex studies with responsibility for all statistical programming activities and ensuring consistency across multiple studi
• esDevelop innovative techniques to solve complex programming problems on a clinical study or program of clinical studies to increase efficien
• cyAssist their manager with programming work projections to aid departmental planni
• ngRepresent statistical programming in client or agency study audi
• tsSupports the Head of Biostatistics, or Manager/Director, Statistical Programming on topics related to programming issues, process improvement, industry trends, and other relevant topi
• csExcellent knowledge and understanding of SAS Base, Macro and O

DS
Qualificati

ons
Educa

tionBachelor's Degree, preferably in Computer Science, Mathematics/Statistics, or a quantitative natural scie

• nce.Extensive knowledge of SAS programming and statistical programming topics relevant to clinical trials including statistical analysis-based procedures and/or indication specific methods; may have expertise in one or more top
• ics.Advanced CDISC knowl
• edgeHands-on experience using

P21E
Exper

ience8 - 10 years’ of experience in developing derived datasets, TFL programming, and submission packages in Clinical Rese

arch.
Special

• SkillsOrganization skills, including attention to detail and multit
• askingCommunication

skills
PC

• SkillsKnowledge of the MS Offic
• e SuiteProficiency in one or more statistical programming languages (includes

SAS, R)
Additional Inf

ormationWe prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute a

nd grow.To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those ar

ound us.

• We offer:Training and career development opportunities i
• nternallyStrong emphasis on personal and profession
• al growthFriendly, supportive working en
• vironmentOpportunity to work with colleagues based all over the world, with English as the company

language
Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great compan

• y to jo
• in!QualityIntegrity &
• amp; TrustDrive &am
• p; PassionAgility & Resp
• onsivenes
• sBelongingCollaborative Pa
• rtnershipsWe look forward to welcoming your ap
• plication.

#LI Remote