Statistical Programmer

Job Information Seniority level : Not Applicable Employment type : Contract Job function : Research, Analyst, and Information Technology Industries : Research Services Responsibilities Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time. Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope. Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician. Develop/maintain/validate aCRFs according to protocol, eCRF, and Indero and/or Sponsor standards and interpretation of CDISC SDTM IG and CT. Develop/maintain/validate specifications and primary or QC statistical programming of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs. Develop/maintain/validate SDTM define.XML/.PDF, cSDRG, ADaM define.XML/.PDF, and ADRG. Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21. Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs. Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables and participate in the realization of these initiatives. Keep oneself abreast with latest industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements. Optional Responsibilities Act as a Lead Statistical Programmer on single studies. Review and provide input into SAPs, TLF shells, and various DM documents (e.g., eCRFs, edit checks). Act as Unblinded Primary or QC Statistical Programmer for IDMCs and IAs. Coach more junior Statistical Programmers. Requirements Education Bachelor’s degree in Statistics, Computing Sciences, or a related field; Master’s degree an asset. Experience At least 1 year of clinical research experience in biotechnology, pharmaceutical, or CRO industry, including 1 year of statistical programming. Knowledge and Skills Significant exposure to clinical trial data, SAP, TLF shells, and specifications. Excellent working knowledge of SAS; SAS certification an asset. Knowledge of XML programming an asset. Good working knowledge of CDISC standards and guidelines; CDISC certification an asset. Good knowledge of drug development process, ICH guidelines (including but not limited to ICH E6, E9, and E9(R1)), relevant HC and FDA regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP. Very organized and detail-oriented, with effective project planning and time management skills. Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands. Must be able to work independently and as part of a team. Strong verbal and written communication skills in English. Company Overview Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe. Perks Flexible work schedule. Home-based position. Ongoing learning and development. Equal Opportunity Employer Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Innovaderm only accepts applicants who can legally work in Argentina. #J-18808-Ljbffr