Senior Statistical Programmer

2 days ago

india beBeeStatistical Full time

Deliver patient treatment innovation by working as a senior statistical programmer with our pharmaceutical client. This role offers autonomy, expertise and exciting opportunities for growth.About the RoleThis position reports to the Director, Biostatistics and Programming within the company's business unit. As a senior statistical programmer, you'll work independently, tracking progress and providing expert technical support. We're looking for a highly experienced professional who will lead clinical development programs and oversee CRO programmers.Main ResponsibilitiesSponsor-dedicated Delivery: Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.Complex Data Analysis: Develop SAS programs generating datasets, complex listings, tables and graphs.High-quality Results: Deliver high-quality statistical programming results developing, validating and maintaining SAS and/or R programs.CRO Oversight: Oversee CRO's statistical programming deliverables ensuring high-quality and meeting timelines.Support Clinical Reports: Support clinical study reports, regulatory submissions, publications, annual DSUR and exploratory analyses.FDA Compliance: Understand and follow FDA regulations affecting clinical trial data reporting.Programming Standards: Contribute to creating, maintaining and documenting programming standards.Development Contributions: Participate in developing CRFs, edit check specifications and data validation plans.Data Transfer: Review and/or author data transfer specifications for external vendor data.Project Coordination: Collaborate with internal and external functions to ensure project timelines are met.Procedures Development: Review and/or author SOPs and/or Work Instructions related to statistical programming practices.To succeed in this role, you'll have:A minimum bachelor's degree in computer science, data science, mathematics or statistics major preferred.7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team.Exceptional SAS programming skills and expertise in statistical programming procedures and processes.Extensive applied experience of CDISC standards, medical terminology and clinical trial methodologies.Experience supporting regulatory submissions and interacting with the FDA.Strong communication and leadership skills.Why Join UsWe enable our employees' success through consistent training, development and support. Our team members enjoy:Opportunities for career growth and professional development.A dynamic and collaborative work environment.The chance to contribute to meaningful projects that drive patient treatment innovation.

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