MS in Statistics, Computer Science, or related field with 3+ years of experience or BS with 5+ years
Proven experience in statistics programming for clinical trials
Strong proficiency in SAS programming and statistical reporting
Familiar with CDISC standards for SDTM and ADaM
Knowledge of FDA and ICH regulations
Strong problem-solving skills
Effective written and verbal communication skills
Experience collaborating within multidisciplinary teams
Responsibilities
Design and code SAS programs for clinical projects
Produce CDISC-compliant datasets including SDTM and ADaM
Create and validate high-quality tables, figures, and listings
Contribute to the design of case report forms and clinical databases
Perform quality control on SAS code and output from other programmers
Program quality checks for raw clinical study data
Review or author specifications for datasets programming
Support adhoc analysis and develop tools for efficiency
Benefits
Comprehensive health insurance
Retirement savings options
Professional development opportunities
Flexible working hours
Collaborative team culture
Full Job Description
Responsibilities:
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 eCRF, SDTM and ADaM datasets specifications for datasets programming
Provides programming support for adhoc analysis.
Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
Requirements:
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.
bility to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
