Job Description

Job Description

Pharma Medica Research (PMRI) is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. We are a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are actively looking for exceptional and passionate individuals who want to work in a learning, innovative team.

We are currently looking for a Clinical SAS Programmer I to join our growing team in our Mississauga location.

The Clinical SAS Programmer I is responsible for developing, validating and running SAS programs, and to provide statistical programming support, especially to Biostatisticians and PK Scientists within Pharma Medica Research Inc (PMRI) . The Clinical SAS Programmer I reports to Manager, Biostatistics & SAS Programming and/or designate.

Duties 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
• Produce SAS analysis datasets and CDISC submission datasets.
• Run programs for the statistical analysis of clinical studies and for the production of TLFs/TLGs.
• Validate statistical programs, output and SAS applications.
• Document data and programming information in accordance to Standard Operating Procedures (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.
• 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 or an equivalent combination of education and experience
• Good knowledge of statistical techniques and experimental design
• Proficient in SAS programming
• Preferably SAS certified
• 1-2 years experience in a clinical research or health care environment
• At least 1 years of experience in SAS programming as a full time work
• Good knowledge of statistical techniques and experimental design
• Excellent knowledge and previous experience in implementing global standards (CDISC CDASH, ODM, SDTM, GCDMP).
• Good knowledge of FDA study requirements specifications for electronic submission.
• Good knowledge of 21 CFR part 11 requirements, including electronic signature and validation, and of electronic submission (eCTD, SDTM).
• Knowledge of 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 skills
• Excellent verbal and written communications skills
• Ability to work independently and as a team member

Why is PMRI the place for you? We offer:

• Competitive compensation plan
• Mentorship Opportunities
• A benefit plan that is fully paid for by PMRI, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD&D, along with a Health Spending and Wellness Spending Accounts and a voluntary RRSP Contribution Plan
• Opportunities for advancement and career progression
• A generous Employee Milestones Awards Program
• Corporate Discounts Program
• Learning Support Programs
• Friendly atmosphere, culture of learning

Please note all applications must be eligible to work within Canada.

PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.

We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.

If you are interested in this exciting opportunity, apply today!

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