23 Aug
|
Sciens Software Technologies
|
Hyderabad
23 Aug
Sciens Software Technologies
Hyderabad
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 fast-paced environment.
- 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)
🏢 Sciens Software Technologies
📍 Hyderabad