Location: home-based or company office in BarcelonaWho we are: Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients' lives. Optimapharm's key priorities are our people and consistently exceeding our client's expectations. With 27 strategically located offices, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America. In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years. We are looking for a Senior Statistical Programmer to join our team in Spain and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.What do we offer?Working in a successful company that's growing and changing every dayWorking with a highly experienced team of clinical research professionalsInternational projects and professional growthCompetitive salary and performance bonusTraining opportunitiesWork from homeFlexible work hoursWho are we looking for?Qualifications and Experience:BS or higher degree in Biostatistics, Mathematics, or related fields. Or a combination of education, training, and work experience5-9 years of experience as a Statistical Programmer in CROs, pharmaceutical companies, biotech companies, or similarKnowledge of GCP and ICH GuidelinesExperience in business development activities, supporting sales teams in the preparation of proposals, and bid defensesExperience in the implementation of technologies and process automation within CROs, pharmaceutical companies, biotech companies, or similarExperience in the implementation of quality systemsSAS Certified Specialist: Base Programming Using SASSAS Certified Professional: Advanced Programming Using SASStrong analytic mindset and logical thinking capabilityComputer and arithmetic knowledge, as well as skills to adapt to different computer systemsAdvanced SAS programming and other statistical softwareExcellent written and oral English communication skillsAbility to define problems, collect data, establish facts, and draw valid conclusionsAbility to communicate effectively with appropriate internal and external contactsAbility to work on multiple projects and to manage project timelinesGood organizational and time management skills and initiativeGood communication and presentation skillsGood people-skills and team playerYour responsibilities:Primarily working with the Data Managers, Statisticians and Clinical Project Managers on ongoing clinical studies to assure results are consistent with expectations, and quality control procedures are followedParticipating in the creation and review of key statistical documents including but not exclusive to:Case Report FormData SpecificationsData Transfer AgreementsStatistical Analysis PlanTables, Listings and Figures ShellsCDISC Mapping DocumentationLiaising with Statisticians and Data Management and Biostatistics Managers at regular intervals to discuss progress and any issues outstandingLiaising with personnel at the sponsor company, or their designates, with Central Event Adjudication Committees, Data Safety Monitoring Committees or any other third parties involved in statistical programming activitiesDeriving and adapting data for analysis, producing patient listings, summary tables, figures and patient profiles, as part of SAS ProgrammingProducing or participating in the validation of SDTM Domains based on the provided Specifications, including Pinnacle 21 execution, producing or reviewing SDTM Specifications, SDTM reviewer guides, Define.XML, and any other documentation required for SDTM derivationProducing or participating in the validation of ADaM Datasets based on the provided Specifications, including Pinnacle 21 execution, producing or reviewing ADaM Specifications, producing ADaM Reviewer guides, Define.XML, and any other documentation required for ADaM derivation, as part of CDISC MappingTraining other project team members to make full and correct use of the company procedures and Biostatistics Reporting EnvironmentParticipating as necessary in sponsor audits, regulatory authority inspections, and other third-party meetingsPerforming necessary administrative functionsEntering and updating data in relevant CTMS modulesBy joining our fast-growing and prosperous team, you will have a great opportunity for further personal growth and career development.
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