Location: Any of the Company's offices in EuropeWho 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 Data Management and Biostatistics team 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 growthPerformance 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 experienceExperience in CDISC (ODM/SDTM/ADaM)Strong 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 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 limited to:Case Report FormData SpecificationsData Transfer AgreementsStatistical Analysis PlanTables, Listings, and Figures ShellsCreation of statistical outputs, with the support of Statisticians, according to specifications including but not limited to:Datasets (e.g., raw, SDTM, ADaM datasets)Randomization ListsTablesFiguresListingsLiaising with Statisticians and Data Management and Biostatistics Managers at regular intervals to discuss progress and any outstanding issuesLiaising and collaborating with corresponding teams in other departments working on the same projectTraining other project team members to make full and correct use of the company Data Capture systemsProducing information/reports directly from the clinical database or via the appropriate procedure to request a new report from the appropriate department or vendorLiaising 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 activitiesParticipating as necessary in qualifications or audits performed to vendors which provide services related to statistical programming activitiesParticipating as necessary in sponsor audits, regulatory authority inspections and other third-party meetings. Ensure that any recommendations are discussed and that solutions are incorporatedDeveloping and maintaining relevant report metrics to share with the overall study team and upper managementSupporting other departments with additional ad-hoc tasks such as preparation of reports, listings, statistical analysis, etc.Maintaining and expanding knowledge base in the area of expertise. Attends courses to develop and keep skills and knowledge current. To comply with continuing education requirementsWorking together with the study team including the biostatistician, data manager, and medical writerBy joining our fast-growing and prosperous team, you will have a great opportunity for further personal growth and career development.
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