Statistical Programmer

Responsibilities:

Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects

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

Acts 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.

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.