BioStat Programmer ABOUT THE COMPANY Axiom Real-Time Metrics, Inc. the pre-eminent eClinical technology and managed services company in Canada delivering clinical trials on a global footprint, is seeking Biostatistical Programmer to join its team A bit about Axiom: • Celebrating 22 years of operations • Have delivered hundreds of studies in over 25 countries • Continuous growth of: • Axiom Fusion eClinical Suite platform • Constant investment in engineering and delivering new features • Consecutively growing our team for the past 11 years • New Clients • Team expansion: • Newly opened California Office ABOUT THE ROLE This is a full-time Biostatistical Programmer position. Candidates should have at least 5 years’ prior experience working in Biostatistical Programming at a CRO/ Biotech /Pharmaceuticals. The Biostatistical Programmer is responsible for the preparation, validation and maintenance of SAS programs to generate SDTM and ADaM SAS datasets, specifications, tables, Listings, Figures and graphical displays of clinical trial and safety data KEY RESPONSIBILITIES • Perform statistical programming, validation, and quality control of the required SDTM and ADaM datasets and output tables/listings/graphs. • Generate complete and efficient analysis data models following approved dataset designs or specifications. • Develop SAS programming codes to independently validate statistical output reports of trial data generated by other programmers or statisticians. • Write, validate and maintains SAS programs to generate SAS datasets, spreadsheets, ASCII files, data listings, tables and graphical displays of clinical trial and safety data. • Contribute to the establishment of client specific programming standards/conventions/procedures for assigned clients when required. • Contribute to the review of Case Report Forms as per CDISC standards. REQUIRED EXPERIENCE & EDUCATION • At least 5+ years relevant work experience in biostatistical programming – CRO/ Pharmaceutical • Bachelor’s Degree in a related field required (e.g. Statistics, Computer Science), Masters preferred. • Proven SAS experience and expertise as demonstrated in previous work (SAS certification is an asset). • Extensive knowledge of CDISC standards programming – SDTM and ADaM. • An understanding of relevant safety and efficacy ICH guidelines as well as relevant clinical trials regulations. • Experience with relational databases. • Demonstrated leadership ability to effectively manage statistical programming activities and integrate them with the entire clinical trial operation. • Good organizational and time management skills with the ability to manage concurrent projects and adjust to changing priorities. • Excellent interpersonal skills; Demonstrated ability to work independently and as part of a team. • Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions. APPLY FOR THIS POSITION Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability. SENIOR CLINICAL TRIALS MANAGER ABOUT THE ROLE KEY RESPONSIBILITIES • Independent oversight of all Trial Management activities pertaining to a study; Study Start Up, REQUIRED EDUCATION & EXPERIENCE • BSc. or recognized equivalent in Health or Science related field ABOUT THE COMPANY • Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROs to provide efficient technology platforms to commence and enhance clinical trials/clinical studies. APPLY FOR THIS POSITION All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please. Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment
Are you a good fit for us? Are we a fit for you?
We want to meet you if you’re smart, hard working, ambitious, and passionate about working in an entrepreneurial environment. Axiom is a great place for you if you’re eager to use all of your skills, interested in growing your responsibilities, and love to have fun while you do great work.
If you’re interested in working with us, but don’t see a role currently listed, please feel free to send us your resume, along with a short summary of your skills and why you’d like to work with us to careers@axiommetrics.com and we’ll be in touch.
Current opportunities
are posted below.To apply please submit your resume, along with a short summary of your skills and why you’re the best fit for this role, below. We look forward to hearing from you.
All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please.
Full Time, Toronto, ON
The Senior Clinical Trials Manager is a full-time role and will oversee all trial management activities pertaining to a study including study start-up, study initiation, study conduct, and close-out; and the implementation of process improvements to facilitate and improve quality of clinical management team. This position reports to the Director of Clinical Management.
Candidates must have10+ years of experience with North America in Technology, CRO, Pharma, or Healthcare Industries. Candidates who do not meet this criterion will not be considered for this role.
Study Initiation, Study Conduct and Close-Out activities and documentation
• Managing day-to-day aspects of running clinical trials
• Management of assigned projects resources on an ongoing basis
• Responsible for ensuring all key client deliverables are met across applicable functional groups
and working to oversee these groups to achieve study milestones
• Financial Management of projects; ensuring Scope of Work remains on track and that study
remains within agreed upon contract and budget.
• Coaching and development of Clinical Management Team members and mentoring of more
junior staff.
• Writing of Axiom Real Time Clinical SOPs and review of other departmental SOPs to ensure
consistency with clinical processes.
• Creation and review of protocol/study design, case report forms (CRFs), source documents, CRF
completion guidelines, informed consent forms and other study documents.
• Performs direct project tasks such as site monitoring, management/oversight of regulatory and
IRB/IEC/REB submissions and/or grant payments as required.
• Develops patient recruitment strategies and materials.
• Coordinates Clinical Monitors on-site and in-house monitoring responsibilities, schedules and
overall project related day-to-day management of the monitoring team to ensure
protocol/ICH/GCP/ISO-14155 adherence.
• Manages aspects of the clinical projects including development of the Clinical Monitoring Plan
(CMP) and the review and sign-off of monitoring reports (including tracking of reports and
assurance of visit frequency per CMP/contract).
• Ensures study master files comply with SOPs, GCPs and other regulations.
• Designs and develops investigator, regulatory, operations, guidelines and training manuals.
• Contributes to business development by attending meetings with potential sponsors; contributes
time and cost estimates (and/or reviews draft proposals for feasibility) for clinical managementrelated activities.
• Provides financial management of assigned projects and provides monthly updates on progress
and performance.
• Oversees scope of study tasks in order to identify any change and support change order
process, if required.
• Monitors the preparation and timely completion of all regulatory filing packages and trip reports
and reviews them for appropriate content.
• 10+ years in a clinical research
• At least 2 years experience as Clinical Project Manger / Clinical Trial Manager in a team leader role
• Must have experience in Pharmaceutical, Medical Device or CRO industry
• Working knowledge of clinical / medical / biology
• Proficiency in Excel, Word, PowerPoint, Project and Outlook
• Knowledge of ICH-GCP
• Clinical Research Postgraduate Certificate, Clinical professional degree e.g. CCRP accreditation is
considered an asset
• Experience with EDC systems (data entry, report review, query resolution and/or configuration) is
considered an asset
• Prior project management experience with a CRO is considered an asset
• We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.
• Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.
• The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer. We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.
without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.Better decisions. Shorter timelines.
Unified Technology. Unmatched Service.