Manager, Statistical Programming

10+ years

Not Disclosed

Canada

10 Jan. 30, 2025

Job Description

Job Type: Full Time Education: BBA/MBA/B.E./BCS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🌟 Now Hiring: Manager, Statistical Programming (Canada) 🌟

💼 Position: Manager, Statistical Programming
🏢 Industry: CRO - Biometrics
📍 Location: Remote (Anywhere in Canada) or Montreal HQ
⏳ Job Type: Full-time

🔎 Job Overview

The Manager, Statistical Programming will oversee statistical programming operations, mentor a team of Statistical Programmers, and ensure deliverables meet Innovaderm's SOPs and quality standards. The role includes managing resource allocation, overseeing clinical trial data programming, performing peer reviews, and contributing to internal initiatives aimed at improving efficiency and quality.

🔑 Key Responsibilities

1. Team Management & Oversight

Mentor and coach direct reports; approve timesheets and leave requests
Conduct performance reviews and align individual goals with company objectives
Collaborate on resource allocation, scope of work, and budget estimation for programming activities
Support project managers in escalation prevention and resolution

2. Statistical Programming Oversight

Review and oversee deliverables such as aCRFs, SDTMs, ADaMs, TLFs, and other reports
Ensure deliverables comply with protocol, SAP, standards, and regulatory requirements
Identify and lead internal initiatives to enhance efficiency and quality of statistical programming
Keep up to date with industry and CDISC standards, ICH guidelines, and regulatory requirements

3. Training & SOP Development

Lead the development and maintenance of training programs for Statistical Programmers
Ensure training content and SOPs are aligned with the latest ICH guidelines and industry standards
Act as a subject matter expert for programming-related topics

4. Additional Responsibilities

Represent Innovaderm in internal/external audits and inspections
Act as the system owner of computerized systems and perform CSV (Computerized System Validation)
Provide oversight on multiple clinical trials

📌 Requirements

🎓 Education:

Bachelor’s degree in Statistics, Computing Sciences, or related field (Master's degree is an asset)

🛠 Experience:

10+ years of clinical research experience, including 7+ years in Statistical Programming and 3+ years in management
Proven experience in resource allocation, budget planning, and managing clinical trial data
Knowledge of SAS and CDISC standards (SAS certification and CDISC certification are assets)

💻 Skills:

Excellent working knowledge of SAS, CDISC standards, ICH guidelines, and FDA/Health Canada regulations
Strong organizational, project management, and time management skills
Ability to thrive in a fast-paced environment and manage competing demands
Strong verbal and written communication skills in English (French is an asset)

🎯 Perks & Benefits

✨ Flexible work schedule
✨ Permanent full-time position
✨ Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
✨ Ongoing learning and development

📌 Work Location: Remote (Anywhere in Canada) or Montreal HQ

📌 Company: Innovaderm (Specialized in Dermatology CRO Research)
📌 Legal Requirement: Applicants must be legally eligible to work in Canada

📩 Apply Now!

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