Highly Skilled Clinical Programming Professional

7 days ago

Gandhinagar, India beBeeStatistical Full time

Seeking an Experienced Senior Statistical ProgrammerA challenging opportunity has arisen for a highly skilled Senior Statistical Programmer to join our clinical programming team.This role requires strong technical proficiency, autonomy, and the ability to collaborate effectively within cross-functional and global teams.We are looking for an individual who can program, validate, and maintain clinical trial datasets and outputs using SAS and R. Experience working on oncology clinical trials is highly desirable, with a strong understanding of oncology-specific endpoints and data structures.This role will involve leading and executing the full spectrum of statistical programming deliverables, including creation and review of SDTM and ADaM specifications, development of SDTM and ADaM datasets, TLF (Tables, Listings, Figures) programming, preparation of Define.xml and reviewer's guides, and developing, enhancing, and maintaining macros to support study and project requirements.We are seeking a motivated and experienced professional who can work independently with minimal oversight, ensuring timely and high-quality deliverables. The ideal candidate will have excellent communication skills, be able to demonstrate a strong sense of ownership and accountability for assigned tasks, and be able to identify opportunities for process improvements and contribute suggestions to strengthen team efficiency.Key Responsibilities:Program, validate, and maintain clinical trial datasets and outputs using SAS and R.Lead and execute the full spectrum of statistical programming deliverables.Develop, enhance, and maintain macros to support study and project requirements.Work independently with minimal oversight, ensuring timely and high-quality deliverables.Demonstrate a strong sense of ownership and accountability for assigned tasks.Identify opportunities for process improvements and contribute suggestions to strengthen team efficiency.Required Skills and Qualifications:Prior experience working in global or geographically distributed teams.In-depth knowledge of CDISC standards and regulatory submission requirements.Experience supporting FDA and PMDA submissions.Ability to manage multiple studies simultaneously and prioritize tasks effectively.Strong documentation, planning, and organizational skills.Experience mentoring or providing technical oversight to junior programmers.Benefits:Opportunity to work on challenging clinical programming projects.Chance to develop and enhance technical skills in SAS and R programming.Collaborative and dynamic work environment.Professional growth and development opportunities.Others:Please note that we are an equal opportunities employer.The successful candidate will be required to undergo a background check prior to commencement of employment.],

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