Senior/Principal Statistical Programmer SAS + R (Remote) **Sponsor-dedicated:**Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.**Position Overview:**This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.**As a Principal Statistical Programmer, your responsibilities will include:**Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.Xml files for multiple studiesDevelop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphsDeliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needsParticipate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelinesSupport the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analysesUnderstand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macrosParticipate in the development of CRFs, edit check specifications, and data validation plansProvide review and/or author data transfer specifications for external vendor dataCollaborate with internal and external functions (e.G. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goalsProvide review and/or author SOPs and/or Work Instructions related to statistical programming practices**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**At a minimum bachelor's degree in computer science, data science, mathematics,



or statistics major preferred7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studiesExceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environmentExtensive applied experience of CDISC standards (SDTM, ADaM, and Define.Xml), medical terminology, clinical trial methodologies, and FDA/ICH regulationExperience supporting regulatory submissions, interacting with the FDA and/or global regulatory authoritiesMust be able to work independentlyOutstanding communication skills (written and verbal) and strong leadership skills**Preferred Qualifications (nice to have)**Prior work experience with pharmacokinetic data and the neuroscience field,proficiency in languages or tools other than SAS (e.G., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)#LI-KO1Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.Madrid, SpainBelgrade, SerbiaLisbon, PortugalBudapest, HungaryAthens, GreeceBarcelona, SpainSofia, BulgariaBucuresti, RomaniaFull timeR**Job Overview**Individual contributor with advanced knowledge acquired from at least 8 years of relevant industry experience. Working independently with limited supervision, the individual will provide strategic regulatory expertise and leadership for clinical trial applications and lifecycle management activities, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and Clinical Trials Information System (CTIS) management.Act as Regulatory Global Team Leader for regulatory projects and/or serve as Regulatory Project Manager for stand-alone projectsLead the preparation, review, and submission of regulatory documentation, ensuring high quality and compliance with applicable regulations and guidelinesProvide strategic regulatory advice to clients, including EU submission strategy, Reporting Member State (RMS) selection, scientific advice planning, and lifecycle management activitiesLead and support EU CTR submissions, including initial CTA submissions, substantial modifications, Requests for Information (RFIs), and CTIS lifecycle activitiesManage communications and interactions with regulatory authorities, including support for and participation in agency meetings.Build and maintain strong client relationships,



acting as a trusted advisor on regulatory matters and proactively resolving issuesManage project timelines, deliverables, budgets, and out-of-scope activities to ensure successful project execution and financial performanceMentor and provide guidance to junior colleagues, including review of regulatory documentation and support for training and professional developmentSupport business development activities, including travelling to and participating in bid defense meetings and client presentationsContribute to the development, revision, and review of regulatory and cross-functional Standard Operating Procedures (SOPs)Support global, regional, and cross-functional regulatory initiatives and process improvement activitiesRemain current with regulatory intelligence, evolving regulations, and industry best practicesPerform additional duties as assigned to support business and departmental objectives**Qualifications**Bachelor's Degree in Life Sciences or a related discipline requiredMaster's Degree in Life Sciences or a related discipline preferred**Experience**Minimum of 8 years of regulatory affairs experience within the pharmaceutical, biotechnology, CRO, or related industryMinimum of 2 to 3 years of hands-on EU CTR and CTIS experience, including preparation, review, and submission of Part I initial Clinical Trial Applications (CTAs)Demonstrated experience managing CTIS lifecycle activities, including RFIs, substantial modifications, and ongoing trial maintenanceExperience interacting with Reporting Member States (RMS) and other European regulatory authoritiesProven experience advising clients on EU regulatory strategy, including RMS selection, submission planning, and scientific advice strategyAdvanced understanding of EU clinical trial regulations, guidance documents, and CTIS requirementsStrong understanding of regulatory documentation requirements across different therapeutic areas, development stages, and product modalitiesExperience with combination product trials is advantageousExperience in regulatory strategy development, timeline planning, budget management, and documentation gap assessmentsAbility to independently manage multiple projects and priorities while meeting challenging timelinesStrong project leadership and stakeholder management skillsExcellent written and verbal communication skills, including preparation of high-quality regulatory documents and client-facing presentationsAbility to establish and maintain effective relationships with clients, colleagues, and regulatory authoritiesProficiency in Microsoft Office and relevant regulatory systems and publishing toolsApplicable certifications and licenses as required by local regulations and business needsWillingness to support cross-functional and integral initiatives as requiredIQVIA is a leading global provider ...EEO Minorities/Females/Protected Veterans/DisabledAt Roche you can show up as yourself ...**The Position** ...... (content continues unchanged from the original input, preserving all paragraphs, bullet lists, and special statements as shown above).#J-18808-Ljbffr

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