Manager 2, Statistical Programming
New
J
JobgetherBiotechnology, Pharmaceutical
IndiaFull-TimeManager
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- 4+ years of experience in clinical data programming
- Required Skills
- PythonR
Requirements
- Bachelor’s degree or higher in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related discipline.
- 4+ years of experience in clinical data programming within the biotechnology, pharmaceutical, CRO, or healthcare industry.
- Strong SAS programming skills with experience working in clinical trial data environments.
- Extensive experience implementing CDISC standards, regulatory guidance, and therapeutic area user guides (TAUG).
- Experience with regulatory submissions and knowledge of requirements such as NDA and ANDA.
- Strong understanding of clinical development processes, statistical concepts, and clinical trial principles.
- Ability to work independently while collaborating effectively with global interdisciplinary teams.
- SAS certification is considered a plus.
- Knowledge of additional programming languages such as R or Python is an advantage.
Responsibilities
- Lead statistical programming activities for Phase I–IV clinical studies across assigned therapeutic areas.
- Plan, execute, and monitor programming deliverables to ensure timely and high-quality project outcomes.
- Create and review CDISC-compliant SDTM mapping specifications and ADaM specifications.
- Develop and oversee SAS programs for SDTM, ADaM datasets, and statistical reports (tables, listings, and figures).
- Support regulatory submission activities by managing documentation packages and compliance deliverables.
- Mentor and coach junior programmers to support team development.
- Contribute to the creation of standard macros, utility programs, and statistical programming standards.
View Full Description & ApplyYou'll be redirected to the employer's site
