Senior Statistical Data Analyst

2 weeks ago

aligarh, India beBeeStatistical Full time

**Job Title:** Principal Statistical Programmer**About This Role**This is an exciting opportunity to work as a Principal Statistical Programmer in a leading pharmaceutical client.You will be working independently with minimal supervision, tracking progress and providing expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to 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 which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphsDeliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needsParticipate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelinesSupport the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analysesUnderstand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macrosParticipate in the development of CRFs, edit check specifications, and data validation plansProvide review and/or author data transfer specifications for external vendor dataCollaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goalsProvide review and/or author SOPs and/or Work Instructions related to statistical programming practices.**Required Skills & Qualifications**At a minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studiesExceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environmentExtensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulationExperience supporting regulatory submissions, interacting with the FDA and/or global regulatory authoritiesMust be able to work independentlyOutstanding communication skills (written and verbal) and strong leadership skills**Benefits & Perks**We enable our employees to succeed through consistent training, development and support.The right candidate will have opportunities to develop their career in a fast-paced and innovative company.**Preferred Qualifications**Prior work experience with pharmacokinetic data and the neuroscience field,proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)

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