Senior Clinical SAS Programmer - CRO > Joboolo CA :
Company : Pharma Medica Research Inc. Location : Mississauga Ontario From : Neuvoo CA
) Clinical SAS Programmer is responsible for developing, validating and running SAS programs, and to provide statistical programming support, especially to Biostatisticians and PK Scientists within PharmaMedicaResearch Inc (PMRI) .
The Sr.
Clinical SAS programmer reports to the VP, Scientific Affairs and/or designate.
Duties and Responsibilities:
Interact with the Project Management, Clinical team, Scientific Affair team, and Clinical Data Management (CDM) team members to negotiate timelines and responsibilities.
Create SAS programs to perform statistical analyses and produce tables, listings, graphs and figures (TLGs/TLFs) as detailed in the Data or Statistical Analysis Plan (SAP/DAP).
Validate SAS programs created by colleagues in the SAS or Biostatistics group.
Review and provide feedback on annotated Case Report Forms (CRFs) to ensure efficient programming.
Review and provide input on Data or Statistical Analysis Plan (SAP/DAP) with respect to the mock TLFs/TLGs.
Provide recommendations and leadership for more efficient methods of programming (i.e.
creation of macros, network folder structures, etc.).
Produce SAS analysis datasets and CDISC submission datasets Run programs for the statistical analysis of clinical studies and for the production of TLFs/TLGs.9.
Validate statistical programs, output and SAS applications.
Document data and programming information in accordance to Standard Operating Procedures (SOPs) and guidelines.
Archive clinical trial data (raw data and analysis datasets), and programming information in accordance to SOPs and guidelines.
Provide support for coding (MedDRA, WHODRUG) auto coding, and Adverse Events (AE) reconciliation.
Provide support for importing data from external sources (lab, eSource) Develop programming coding standards and/or follow them.
Develop and/or modify SAS or SQL code for data controls, report generation, or other data related programming.
Conceptualize, design, and implement programs and processes to standardize statistical programming across projects.
Work with the Quality Assurance (QA) group in the development/revision and implementation of SOPs as required.
Ensure compliance with appropriate SOPs, Regulatory Authorities, Good Clinical Practice (GCP) and ICH guidelines.
Participate in training sessions.
Other duties as required.
Qualifications:
Bachelor degree in computer science, mathematics, statistics or health sciences and good knowledge of statistical techniques and experimental design Proficient in SAS programming; Preferably SAS certified.
3 - 5 years experience in a clinicalresearch or health care environment working in SAS Programming with knowledge of GCP (Good Clinical Practices).
Skilled at statistical techniques and experimental design Working Knowledge of Drug and/or Device Study Development Processes; experienced with FDA study requirements Excellent knowledge and previous experience in implementing global standards (CDISC CDASH, ODM, SDTM, GCDMP); experienced with 21 CFR part 11 requirements, including electronic signature and validation, and of electronic submission (eCTD, SDTM).
Experienced in Coding Clinical Data processes using standardized dictionaries (MedDRA, WHODRUG).
Working knowledge of current ICH and FDA/TPD table formats and statistical analysis practices.
Excellent computer skills, experience with a programming language like SQL, PL/SQL, Java, or C would be a plus.
Excellent problem solving and organizational skills with ability to work in a high volume and strict deadline environment Excellent interpersonal, verbal and written communications skills Ability to work independently and as a team member If interested in this position, apply today! Great work environment with competitive salary and benefits program. PharmaMedicaResearchInc. MississaugaOntario
