Clinical SAS Programmer

5 months ago

Remote, India TruMinds Technology Inc Full time

Serves as a stat programming expert or point of contact for assigned clinical studies under close/limited supervision of the stat programming project lead Primary Responsibilities Include:

- Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)
- Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets
- Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements
- Provides input in the design and development of case report forms and clinical databases
- Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs
- Programs quality checks for clinical study raw data and report the findings to Data Management
- Provides input in the design and development of case report forms and clinical study databases
- Reviews or author aCRF, SDTM and ADaM datasets specifications for datasets programming
- Provides programming support for adhoc analysis
- Manages timelines and schedules of specific phases of projects with internal personnel and external vendors
- Acts as lead programmer for a study
- Reviews or validates statistical deliverables of vendors for assigned project(s)

Desired Education and Skills:

- MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years.
- Experience in providing statistical programming support to early and late phase clinical trials.
- Excellent skills in SAS programming and statistical reporting.
- Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
- Familiarity with FDA and ICH regulations and guidelines.
- Excellent problem-solving skills.
- Good written and verbal communication skills and organizational and documentation skills.
- Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
- Ability to prioritize and multi-task effectively
- Demonstrated positive attitude and the ability to work well with others.

Pay: ₹400,000.00 - ₹465,000.00 per month

Application Question(s):

- Experience in SDTM and ADaM dataset

**Experience**:

- SAS Programming: 5 years (required)
- Ontology: 5 years (required)

Work Location: Remote

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