Principal Statistical Programmer - Sponsor Dedicated, EMEA

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/77up4g

ppAs a bPrincipal Statistical Programmer /b in our bsponsor-dedicated /b Flexible Solutions business unit, you are central to the successful delivery of complex projects for a renowned, innovative and global top pharmaceutical company. /p pYou will be involved in liaising with the entire study team as needed, including Clinical, Medical Writing, Safety and Biometrics. It is a great opportunity to see more how this works from a Big Pharma perspective, whilst still being part of a global CRO with opportunity for future career growth. /p pThis position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas. /p pYou can be 100% home-based in EMEA or you can work from our local office in your home country. /p h3Your Responsibilities /h3 ul liPlan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, etc. /li liOversee SDTM, ADaM and TLF development, perform Senior Review of outputs. /li liLiaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing and additional development needs and analyses. /li liSupport/oversee submission activities (especially in late phase team). /li liEnsure all activities are conducted efficiently, with appropriate set-up of needed tools and macros,



prioritizing quality at all times. /li liMentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs while ensuring adherence to department standards and processes. /li /ul h3Your Profile /h3 ul liIdeally, a degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc. /li liIn lieu of the above: professional experience in statistical programming within clinical trials in a biotech, CRO or pharmaceutical company. /li liSolid experience with complex clinical trials (minimum 5 years) and the corresponding data sets content (safety and efficacy) and endpoints. /li liIdeally you will have knowledge in all aspects of clinical trials, from initial study set-up to study completion, with an understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management. /li liExpert knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs. /li liBroad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guides and submission standards. /li liAn autonomous, collaborative work style, a curious mind and a keen attention to detail. /li liFluency in English – both verbal and written – is a must. /li /ul pLearn more about our EEO Accommodations request here. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/77up4g