Principal Statistical Programmer

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

Job summary

A biotechnology company is seeking a SAS Programmer to oversee programming efforts for clinical trials. Responsibilities include generating datasets and managing project tasks. The ideal candidate has extensive SAS programming experience in the biotech field and strong analytical skills. The position is based in Canada, offering opportunities to work with innovative projects in the healthcare industry.

Qualifications

• 8+ years SAS programming experience in Biotech or clinical trials.
• Knowledge of ICH guidelines and CDISC data structures.
• Experience with Oncology and Rare Diseases preferred.

Responsibilities

• Support SAS programming efforts for projects and studies.
• Generate SDTM and ADaM datasets, tables, and figures.
• Interact with clients and lead statistical programming efforts.

Skills

Excellent organizational skills

Excellent communication skills

Excellent problem solving skills

Ability to program/QC complex datasets

Attention to detail

Education

Bachelor's degree in Statistics, Mathematics, Computer Science or related field

Tools

SAS

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.

Create a Job Alert

Interested in building your career at Precision for Medicine? Get future opportunities sent straight to your email.

Apply for this job

indicates a required field

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Education

School Select...

Degree Select...

Select...

Start date year

LinkedIn Profile

What is your desired salary? *

Are you authorized to work lawfully in the country/location for which you are applying? * Select...

Will you now or in the future require Precision Medicine Group to commence (sponsor) an immigration case in order to employ you (for example, work visa application or work visa transfer, or other-employment based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status. * Select...

Have you ever worked for Precision Medicine Group or one of its affiliated companies? * Select...

If yes, when and which company?

Have you ever interviewed with Precision Medicine Group or an affiliated company? * Select...

If yes, when and which company?

Are you currently subject to a Non-Compete or Non-Solicit with your current employer? * Select...

I certify that the information on this application, my resume and any supporting documentation I provide is complete and accurate to the best of my knowledge.If this application leads to employment, I understand that false or misleading information in my application, resume or interview may result in my release or termination of employment.I authorize the Company or its agents to confirm all statements contained in this application and/or resumes as it relates to the position I am seeking and to the extent permitted by federal, state, or local law. I agree to complete any required authorization forms for the background investigation.I authorize and consent to, without reservation, any party or agency contracted by this employer to furnish the above-mentioned information. I hereby release, discharge, and hold harmless, to the extent permitted by federal, state, and local law, any party delivering information to the Company or its duly authorized representative pursuant to this authorization from any liability, claims, charges or causes of action which I may have as a result of the delivery or disclosure of the above requested information and all other persons, corporations, or organizations furnishing such information.If hired I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the United States. I also understand that the Company employs only individuals who are legally eligible to work in the United States.This application will remain active for 60 days. Any applicant wishing to be considered for employment after that time must reapply.UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100. * Select...