Principal Statistical Programmer

Cytel; Toronto; On-site; CAD 80,000 - 100,000; Full time

Job summary

A leading clinical data solutions provider in Toronto is seeking an experienced professional to provide technical leadership in SAS programs and applications. The ideal candidate should possess a master’s degree in biostatistics or a related field with over 8 years of experience within the pharmaceutical industry. Responsibilities include ensuring compliance with FDA regulations, performing quality control on SAS code, and conducting technical briefings. Excellent communication skills and adaptability are essential for this role.

Qualifications

• 8+ years of experience in the pharmaceutical industry for MS holders.
• 10+ years of experience in the pharmaceutical industry for BS holders.

Responsibilities

• Provide technical leadership in SAS programs and applications.
• Ensure compliance with company SOPs and FDA regulations.
• Perform quality control checks of SAS code.
• Review and maintain study documents.
• Conduct briefings and participate in technical meetings.

Skills

Expert in SAS language, procedures, and options

R programming experience

Excellent communication skills

Adaptability and flexibility

Education

MS in biostatistics or related field

BS in biostatistics or related field

Job description

Key Responsibilities:

• Provide technical leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures , and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor

• Provide technical leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission

• Ensure compliance with company SOP'S and FDA/ICH/GCP regulations

• Perform quality control checks of advanced SAS code for datasets and output produced by other statistical programmers

• Review, maintain study documents per standard process

• Program, test, and document global utility programs and tools in accordance with standards and validation procedures

• Conduct briefings and participate in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects

• Perform lead duties when called upon

• Perform other duties as assigned

Technical and Communication Skills:

• Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH

• R programming experience is a plus

• Excellent and transparent communication skills and ability to interact across multiple functions

• Adaptability and flexibility for when priorities change

Preferred Education and Experiences:

• MS in biostatistics or a related field, with 8+ years of experience in pharmaceutical industry, or BS in biostatistics or a related field, with 10+ years of experience in pharmaceutical industry

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.