MS in Statistics, Computer Science, or related field (3 years experience) or BS with 5 years experience.
Proven track record in statistical programming for clinical trials.
Strong expertise in SAS programming and statistical reporting.
Knowledge of CDISC standards and FDA submission requirements.
Understanding of FDA and ICH regulations.
Excellent problem-solving and communication skills.
Ability to collaborate in multidisciplinary teams.
Proficient in organizational skills and managing multiple tasks effectively.
Responsibilities
Design and code SAS programs for clinical projects using BASE/SAS and SAS MACROS.
Deliver CDISC-compliant SDTM and ADaM datasets.
Create and validate timely tables, figures, and listings (TFLs) meeting study objectives.
Conduct quality control checks on SAS code and outputs from other programmers.
Program checks for clinical study raw data and report findings.
Lead programming efforts for specific studies and manage project timelines.
Review and validate specifications for eCRF, SDTM, and ADaM datasets.
Benefits
Opportunities for professional growth and advancement.
Collaborative work environment across multidisciplinary teams.
Exposure to diverse clinical projects and methodologies.
Potential to influence global tools and processes in programming.
Flexibility in work arrangements.
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)
Manages timelines and schedules of specific phases of projects with internal personnel and external vendors
cts as lead programmer for a study
Reviews or validates statistical deliverables of vendors for assigned project(s)
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.
bility to prioritize and multi-task effectively
Demonstrated positive attitude and the ability to work well with others.
