Sigma-Chiconsulting

Vendor Support Services

Vendor Management Services (Vendorship Model)

Dual-City Delivery Model – Hyderabad & Visakhapatnam

We operate dedicated delivery pools in Hyderabad and Visakhapatnam with identical skill distribution, ensuring uninterrupted business continuity and risk mitigation.

RoleExperienceCoverage
Principal Programmer / Biostatistician12–18 yrsSAP development & review, regulatory strategy, sponsor governance, complex studies
Senior Programmer7–12 yrsSDTM/ADaM leadership, reviewer interaction, submission deliverables
Stats-II Programmer4–7 yrsIndependent ADaM, TLF programming, advanced QC
Stats-I Programmer2–4 yrsSDTM mapping, TLF execution, validation support

Additional Strengths

  • Backup coverage for all critical roles

  • Cross-trained therapeutic teams

  • Rapid ramp-up within 2–4 weeks

Programmer SOPs – End-to-End Coverage

Our SOP framework is audit-ready and sponsor-aligned, covering the full programming lifecycle.

Programming & Delivery SOPs

  • SDTM & ADaM development (CDISC compliant)

  • TLF programming (Tables, Listings, Figures)

  • Independent QC & double programming

  • Standardized programming practices & macro usage

Governance & Compliance SOPs

  • Change control & version management

  • Submission lock & handover process

  • Audit and inspection readiness

  • Data privacy & access control (21 CFR Part 11)

AI-Based Tables Validation Tool

Our proprietary AI-enabled validation tool enhances quality and accelerates delivery.

Key Capabilities

  • Automated shell vs output comparison

  • Population count verification

  • Statistical method consistency checks

  • Footnote & formatting validation

  • Version-to-version comparison

  • Full audit-trail ready validation logs

Business Impact

  • 40–60% reduction in QC effort

  • Faster DBL to CSR timelines

  • Reduced late-stage error risk

Live demo available (30–45 minutes)

Governance, Leadership & Escalation Model

Primary Point of Contact

  • Associate Director – Statistical Programming

  • 14+ years of industry experience

  • Therapeutic areas: Oncology, CNS, CV, Rare Diseases

  • Regulatory exposure: FDA, EMA, PMDA

  • Expertise: SAS, R, Python, CDISC, Automation

Escalation Structure

  • Study-level leadership

  • Program-level oversight

  • Executive steering support

Commercial Model – Minimum Hourly Rates (INR).

We offer flexible and transparent pricing tailored to your project needs:

  • Customizable engagement models: Full-Service, Hybrid, or Project-based

  • Competitive rates aligned with industry standards

  • Volume and long-term discounts to maximize your investment

  • Blended rate options for optimal resource utilization

  • Scalable teams for quick ramp-up and smooth delivery

  • Clear, predictable billing with no hidden costs

Standard R Programmer Outputs