Hi Hope you are doing well. This is Prasad from Kutir Corporation, We currently have an requirement for a Sr MS Dynamics 365 CRM Developer and are reaching out to see if you have any suitable profiles available. If so, kindly share the updated resumes of available consultants along with expected hourly pay rate and visa status. Job Title: Senior Statistical Programmer (Remote – Canada) Location: Remote Duration: 6+ Months Contract We are seeking an experienced and detail-oriented Senior Statistical Programmer to join our growing team. This is a remote position open to candidates residing in Canada. The ideal candidate will bring robust hands-on expertise in statistical programming with a focus on end-to-end clinical trial data processes including SDTM, ADaM, TLFs, and associated documentation. Strong oncology domain knowledge and hands-on experience with ADTTE and oncology TLFs is essential for success in this role. Key Responsibilities: - Develop, validate, and maintain SDTM and ADaM datasets in compliance with CDISC standards.
- Program and validate Tables, Listings, and Figures (TLFs) for clinical trial submissions and reports.
- Prepare and review study-level documentation including SDRG, ADRG, Define.xml, and Pinnacle 21 reports.
- Ensure programming deliverables meet quality standards and regulatory compliance requirements.
- Work cross-functionally with statisticians, data managers, and medical writers to support clinical study objectives.
- Provide programming support for oncology trials, with a focus on ADTTE derivations and efficacy/safety TLFs.
- Mentor junior programmers and contribute to process improvements and best practices.
Required Qualifications: - Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field.
- Minimum 5 years of experience in statistical programming within the pharmaceutical or CRO industry.
- Strong knowledge and hands-on experience with CDISC standards (SDTM, ADaM).
- Proven experience with oncology studies, particularly ADTTE and oncology-specific TLFs.
- Proficiency in SAS programming (Base, Macro, SQL, and/or Graph).
- Familiarity with regulatory submission standards and tools (e.g., Pinnacle 21, Define.xml creation).
- Ability to work independently in a remote environment and manage multiple priorities effectively.
- Excellent communication and documentation skills.
Regards Prasad prasad@Kutirtech.com | 