We are seeking an experienced and detail-oriented Senior Statistical Programmer with 6 to 10 years of hands-on experience in clinical trial programming.
The ideal candidate will have extensive experience in end-to-end clinical study execution, with deep technical specialization in ADaM dataset creation and Tables, Listings, and Figures (TLFs) generation. While working knowledge of SDTM is essential for full lifecycle support, this role specifically emphasizes complex analysis dataset derivation, efficacy/safety reporting, and TLF delivery. Proven proficiency in SAS is required, while experience with R programming and SQL is a strong added advantage.
Key Responsibilities
1. ADaM & TLF Programming (Primary Focus)
· Lead and perform end-to-end programming activities for the derivation and validation of ADaM datasets (Safety, Efficacy, PK/PD) following CDISC ADaMIG standards.
· Develop, validate, and execute complex programs to produce Tables, Listings, and Figures (TLFs) for Clinical Study Reports (CSRs), interim analyses, and ad-hoc requests.
· Author and review detailed ADaM dataset specifications and mock-up shells in close collaboration with Biostatisticians.
· Perform quality control (QC) / validation programming (independent double-programming) for critical ADaM datasets and primary/secondary analysis outputs.
2. End-to-End Study Leadership
· Serve as the Lead Programmer for assigned clinical trials (Phases I–IV or ISS/ISE integration studies) from protocol initiation through regulatory submission.
· Provide end-to-end technical oversight, ensuring seamless data flow from raw data through SDTM, ADaM, and final reporting.
· Review key study documents including the Statistical Analysis Plan (SAP), Annotated CRFs (aCRF), and data management specifications.
· Participate in regulatory submission package preparation (e.g., Define.xml, ADRG/SDRG, Pinnacle 21 compliance execution).
3. Process & Technology Integration
· Write reusable SAS macros and standard code templates to streamline delivery processes.
· Leverage R programming and SQL (where applicable) to support modern data workflows, automated reporting, or ad-hoc data manipulations.
· Mentor and provide technical guidance to junior programming staff.
· Ensure strict adherence to company SOPs, ICH-GCP, and regulatory standards (21 CFR Part 11, FDA/EMA requirements).
Required Qualifications & Experience.
Experience: 6 to 10 years of statistical programming experience in a CRO or Pharmaceutical/Biotech environment.
Core Technical Expertise:
· Advanced expertise in SAS programming (BASE, STAT, GRAPH, MACRO).
· Deep knowledge of CDISC standards, specifically ADaMIG and TLF creation.
· Solid foundational knowledge of SDTMIG and raw data structures to ensure accurate end-to-end traceability.
· Demonstrated experience in leading end-to-end clinical studies.
Soft Skills: Strong analytical problem-solving skills, high attention to detail, and excellent verbal and written communication skills.
Preferred / Added Advantage Skills
· R Programming: Practical experience in data manipulation or reporting using R (e.g., Tidyverse, pharmaverse).
· SQL: Proficiency in writing SQL queries for database querying and data processing.
· Regulatory Submissions: Direct experience in pooled analyses (ISS/ISE) and preparing regulatory eCTD submission packages.
SAS Programming, Base SAS, SAS STAT, SAS GRAPH, SAS MACRO, Statistical Programming, ADaM, ADaMIG, SDTM, SDTMIG, CDISC, Tables, Listings & Figures (TLFs), Clinical Trial Programming, Clinical Study Reports (CSR), Clinical Data Analysis, Clinical Research, Statistical Analysis Plan (SAP), Annotated CRF (aCRF), Define.xml, ADRG, SDRG, Pinnacle 21, Regulatory Submissions, eCTD, ISS, ISE, Data Validation, Quality Control (QC), Double Programming, Clinical Data Management, R Programming, Tidyverse, Pharmaverse, SQL, Data Manipulation, Reporting Automation, SAS Macros, Clinical Data Standards, ICH-GCP, FDA, EMA, 21 CFR Part 11, Biostatistics, End-to-End Study Management, Mentoring, Problem Solving, Analytical Skills, Communication Skills.