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Senior Statistical Programmer (India)

7+ years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: BA/BS/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: Senior Statistical Programmer - India 🇮🇳

💼 Position: Senior Statistical Programmer
🏢 Industry: CRO - Biometrics
📍 Location: India
Job Type: Full-time

🔎 Job Overview

As a Senior Statistical Programmer, you will lead clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs), SDTM datasets, ADaM datasets, and TLFs. You will ensure adherence to industry standards and regulatory requirements while collaborating with cross-functional teams to deliver high-quality outcomes. You will also support data cleaning activities, participate in efficiency improvement initiatives, and use tools like Pinnacle 21 to validate datasets.

🔑 Key Responsibilities

1. Programming & Validation

  • Lead statistical programming for clinical trials
  • Develop and validate SDTM, ADaM datasets, and TLFs
  • Ensure compliance with CDISC standards and regulatory guidelines

2. Data Management & Quality

  • Support data cleaning and resolve issues with statistical data
  • Use global SAS macros for efficient programming and validation of datasets
  • Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21

3. Collaboration & Mentorship

  • Collaborate within Biostatistical study teams and other departments
  • Mentor junior Statistical Programmers

4. Continuous Improvement

  • Participate in internal initiatives to improve statistical programming processes
  • Stay current with the latest industry standards and regulatory requirements

📌 Requirements

🎓 Education:

  • Bachelor’s degree in Statistics, Computing Sciences, or related field; Master’s degree a plus

🛠 Experience:

  • At least 7 years of clinical research experience, with 5 years in Statistical Programming and 2 years as Lead Statistical Programmer

💻 Skills:

  • Expertise in clinical trial data, SAP, TLF Shells, and CDISC standards
  • Proficiency in SAS programming; SAS certification an asset
  • Knowledge of XML programming and ICH guidelines
  • Strong communication skills in English

🎯 Perks & Benefits

Flexible home-based work schedule
Ongoing learning and development opportunities
Collaborative work environment

📌 Company: Innovaderm (Specialized in Dermatology CRO Research)

📩 Apply Now!