Lead Data Analyst

2 weeks ago

kozhikode, India beBeeStatistical Full time

Senior Statistical Programmer RoleAs a highly experienced Senior Statistical Programmer, you will play a key role in our clinical development programs. You will oversee CRO programmers and ensure that data summaries are delivered in a consistent, high-quality manner.Key Responsibilities:Generate SDTM, ADaM specifications, datasets, reviewer's guide, and define.xml files for multiple studiesDevelop SAS programs to generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics), and complex graphs in collaboration with a StatisticianDeliver high-quality statistical programming results by developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needsOversee CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet pre-specified timelinesSupport the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analysesUnderstand and follow FDA regulations affecting the reporting of clinical trial data, including good clinical practice and guidelines for electronic submissionsContribute to creating, maintaining, documenting, and validating standards for programming tools, outputs, and macrosParticipate in the development of CRFs, edit check specifications, and data validation plansReview and/or author data transfer specifications for external vendor dataCollaborate with internal and external functions (e.g., software vendors, clinical development partners) to ensure meeting project timelines and goalsReview and/or author SOPs and/or Work Instructions related to statistical programming practicesQualifications:At least a bachelor's degree in computer science, data science, mathematics, or statistics7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar teamExceptional SAS programming skills and expertise in developing and implementing statistical programming procedures and processes in a clinical development environmentExtensive applied experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulationExperience supporting regulatory submissions and interacting with regulatory authoritiesAble to work independentlyOutstanding communication and leadership skillsRequirements:Proficiency in R programming language is an added advantageKnowledge of electronic data capture systems and IRT systems is beneficialStrong analytical and problem-solving skillsExcellent attention to detail

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