Principal Statistical Programmer

Precision for Medicine; Canada; Remote; CAD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled SAS Programmer to support and lead programming efforts for clinical trials. This role involves developing and validating SAS programs, overseeing project management, and ensuring compliance with industry standards. The ideal candidate will have extensive experience in the biotechnology sector, particularly in clinical trials, and will be responsible for generating datasets and reports that drive critical analyses. Join a dynamic team where your expertise will shape the future of healthcare data analysis and contribute to groundbreaking research.

Benefits

Health Insurance

Retirement Plan

Flexible Working Hours

Professional Development Opportunities

Paid Time Off

Remote Work Options

Wellness Programs

Qualifications

• 8+ years SAS programming experience in Biotech or clinical trials.
• Knowledge of ICH guidelines and FDA regulations.

Responsibilities

• Lead SAS programming efforts for clinical trials and studies.
• Generate SDTM and ADaM datasets for data analysis.

Skills

SAS Programming

Project Management

Statistical Analysis

Quality Control

Communication Skills

Organizational Skills

Education

Bachelor's degree in Statistics

Bachelor's degree in Mathematics

Bachelor's degree in Computer Science

Tools

SAS

CDISC Standards

Job description

Position Summary:
Support, lead, and provide oversight to SAS programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet project needs; Provide technical expertise to the development of programming standards and procedures. May serve as the project manager for assigned projects.

Essential functions of the job include but are not limited to:

• Review CRFs, edit check specifications and table mock-ups
• Create specifications for SDTM and ADaM datasets
• Oversee generation of blankcrf.pdf aCRFs and define.xml files
• Generate SDTM and ADaM datasets, tables, listings, and figures to support the analysis of clinical trials data
• Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Perform quality control (including documentation) for SAS programs and other study documents (e.g., presentations and reports)
• Review, maintain and approve study documents per standard procedures
• Interact with clients and lead statistical programming efforts for the project team; serve as the primary project team representative, delegating work as appropriate
• Prepare reports (i.e. patient profiles, SAP related outputs, interim analysis) for Data Monitoring Committees (DMCs)
• Assist with training of new hires; provide ongoing training and mentorship for statistical programmers
• Participate Lead or oversee in the development and maintenance of departmental procedures/standards
• Program, test and document global utility programs and tools in accordance with standards and validation procedures
• Provide technical oversight and leadership when needed for analysis and reporting; may serve as the project manager for assigned projects
• Other duties as assigned

Qualifications:

Minimum Required :
Bachelor's degree in Statistics, Mathematics, Computer Science, or in a related field; 8+ years SAS programming experience (preferably in Biotech / clinical trials / related industry)

Other Required:

• Knowledge of industry standards, such as ICH guidelines, CDISC data structures, 21 CFR Part 11 and FDA guidelines
• Broad programming experience supporting clinical trials in the Biotechnology / Pharmaceutical / CRO Industry

Preferred:

• SAS Certified Advanced Programmer for SAS 9 or equivalent proficiency
• Broad experience with Oncology and Rare Diseases
• Broad experience with ISS/ISE programming and submissions

Skills:

• Excellent organizational skills, time management, and the ability to coordinate workload to meet established deadlines
• Excellent communication and interpersonal skills to effectively interface with others (both internally and externally to foster client relationships)
• Excellent problem solving skills
• Ability to program/QC more complex analysis datasets and outputs (i.e. tables, ADaMs, efficacy related outputs, figures) in an efficient and readable manner
• Demonstrated proficiency in interpreting statistical analysis plans
• Sound judgment/decision making
• Ability to establish and teach others to maintain effective working relationships with coworkers, managers, and clients
• Service oriented, accountable and flexible
• Keen attention to detail in reviewing outputs for project deliverables
• Ability to fulfill a variety of data-related roles while building company strength and experience in data activities
• Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to ourCA Privacy Notice .

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail] .

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

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