Job Title

Requirement: We are looking for an associate with at least 2-8 years of experience for Statistical programmer position and 8+ years for senior programmer position. Incumbent must have strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. They should be able to manage communication with customers, track and ensure quality on-time deliverables, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time.Key asks:Ability to handle programming activities independentlyCore and solid ADaM and TFL experience, eSub will be an added valueStrong SAS experience, any added experience of R will be goodTherapeutic area experience – vaccines, I&I, oncology, biomarkers and PROsDetailed JD:TopicDetailsSDTM/ADAM Model and IGThorough understanding of SDTM/ADAM concepts and challenges. Good hold on the TAUG’s and related guidelines. Hands on experience in implementing SDTM/ADAM concepts across TA’s and various phases of clinical trains. Good understanding on previous versions on SDTM/ADAM guidelinesStudy ReportingSuggest creative solution approach for various business requirements to solve complex SDTM/ADaM Mapping and Programming problems (e.g. creates modular reusable code, develops standard code or utilities, and designs interconnected programs. Review and author documents related to deliverables (User Guide, CDARS Mapping Specification, OCF, Test Plans, SAS Logs and Programs). Good understanding of all study documents including Protocol, SAP, Mock Shells, LOT, Analysis plan etc. Hands on experience of development and review of study specific tables, listings and figures for various phases of clinical trials and across TA’s.SAS ProgrammingExpertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies; review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SASand other advanced SAS components. Mentor and supervise developer to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements.Controlled TerminologyGood understanding of code list and value list concepts. Expertise in managing NCI codelist and tracking its updates. Exposure to CDASH, SDTM/ADaM and ADaM lineage conceptsOther CDISC IGsExposure to Medical Device, Associated Patients, Oncology and other specific guidelines around CDISC SDTM/ADaM.Hands on exposure in managing few of these activitiesDeveloping Mapping SpecsHands on experience in developing mapping specs for SDTM/ADaM. Desirable to have hands on experience in developing mapping specs for a TA or global level SDTM/ADaM mappings. Senior Statistical Programmer is responsible for review of developed SDTM/ADaM mapping specificationsSDTM/ADaM Dataset ProgrammingHands on experience in generating SDTM/ADaM datasets using SAS programming or other tool-based approach.SDTM/ADaM Compliance & DefineHands on experience generating define.xml files, experience in performing SDTM/ADaM compliance checking using P21 or other compliance checks.ValidationImplement QA and QC validation in accordance with Departmental SOP’s for deliverables including:Formal study reportsData reviewPresentationsAdhoc-requestsAlong with this the candidate must have good understanding ofExposure to software development or global macro development processExposure in developing user specifications, developing global macros, unit testingExperience in handling development and maintenance projectsChange Management and Version control processClinical guidelines understanding like ICH-GCP, SDTM/ADAM IGs etc.Client management, communication, project management and other soft skillsGood team player