24 Aug
|
Sciens Software Technologies
|
India
24 Aug
Sciens Software Technologies
India
Primary Responsibilities
Develop and validate SAS programs for the analysis and reporting of clinical trial data in accordance with study protocols, statistical analysis plans (SAPs), and regulatory requirements.
Perform data manipulation, transformation, and cleaning using SAS programming techniques to ensure data quality and integrity.
Perform end-to-end statistical programming activities (e.g., SDTM, ADaM, TLF).
Review and provide input into statistical analysis plans, data management plans, and other study documents.
Conduct peer review of SAS programs and output to ensure accuracy, consistency, and compliance with company standards and regulatory guidelines.
Review complete CDISC package such a Define.xml, study RTF ect.
Participate in study team meetings and provide programming expertise and support as needed.
Stay current with industry trends, best practices, and regulatory requirements related to SAS programming in clinical research.
Ability to prioritize tasks, manage multiple projects simultaneously, and meet tight deadlines.
Lead and mentor a team of statistical programmers.
Oversee project timelines, resource planning and deliverables.
Develop, validate and maintain SAS programs.
Ensure outputs are accurate, reproducible, and meet regulatory standards
(e.g., CDISC, FDA, EMA).
Provide training and mentor junior programmers.
Familiarity with clinical trial processes, ICH guidelines, and regulatory submission requirements.
Participate in audits and inspections as needed.
Manage multiple priorities in a quick-paced setting.
Strong analytical and problem-solving skills with attention to detail.
Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team workplace.
Collaborate with biostatisticians, clinical data managers, and other stakeholders to understand data requirements and programming specifications.
Contribute to the creation and maintenance of standa
📌 Sas Programmer Hyderabad (India)
🏢 Sciens Software Technologies
📍 India