Manager, Statistical Programming

World Courier

India

Remote

INR 2,000,000 - 3,600,000

Full time

4 days ago
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Job summary

Cencora is seeking an experienced Statistical Programmer to lead development of SAS programs and analysis datasets for clinical studies and regulatory submissions. The role requires deep CDISC SDTM/ADaM knowledge and hands-on SAS/R skills in a fast-paced environment.

The candidate should have 7+ years in clinical statistics, with the ability to validate code, produce TFLs, and collaborate across cross-functional teams, including biostatistics and data management.

Qualifications

  • Master's or Bachelor's degree in Data Science or related field (Statistics, computational biology, bioinformatics, computer science).
  • Strong hands-on SAS programming experience with CDISC standards (SDTM/ADaM).
  • Experience with SAS and R statistical programming and regulatory submission deliverables.

Responsibilities

  • Develop, validate, and maintain SAS programs and TFLs for efficacy and safety analyses.
  • Create and quality-check datasets per CDISC SDTM/ADaM standards and study requirements.
  • Collaborate with Biostatistics, Data Management, and Clinical teams to resolve data issues.
  • Contribute to programming documentation, standard processes, and reusable macros/templates.
  • Provide guidance to junior programmers and participate in code reviews and validation.

Skills

SAS programming
CDISC SDTM/ADaM
R programming

Education

Master's or Bachelor's degree in Data Science (Statistics / Bioinformatics / CS)

Tools

SAS
R

Job description

## Manager, Statistical ProgrammingApply: APAC > India > Remote: Full time: Posted Today: R2615989Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!# **Job Details****Job Summary:** We are looking for an experienced Statistical Programmer with strong hands-on expertise in SAS programming and deep knowledge of CDISC standards, including SDTM and ADaM. This role will be responsible for independently developing, validating, and maintaining SAS/R programs including development of analysis datasets and production of TFLs to support clinical studies and regulatory submission deliverables, with oversight and guidance responsibilities. It requires a deep understanding of clinical trial design and data analysis. **Key Responsibilities:** * Develop and validate datasets in compliance with dataset specifications following CDISC standards (SDTM and ADaM) and study requirements.* Program, generate, and quality check TFLs for efficacy and safety analyses for clinical study report or regulatory submissions following SAP, mock shells and internal standards.* Perform SAS and R statistical programming.* Contribute to the preparation and review of programming deliverables across multiple studies or projects.* Collaborate closely with Biostatistics, Data Management, Clinical, and other cross-functional teams to resolve data issues and support study objectives.* Support creation and maintenance of programming documentation, specifications, and standard processes.* Contribute to process improvements, standardization efforts, and development of reusable programming tools such as macros and templates.* Ensure timely delivery of high-quality programming outputs in a fast-paced clinical development environment.* Provide technical guidance and day-to-day support to junior programmers or peers as needed.* Participate in code review, debugging, and validation activities to support quality and consistency across programming deliverables.* Validating/debugging the codes written by other team members.* Maintain quality and timeliness of project work..**Qualifications:** * Master's or Bachelor’s degree in Data Science such as Statistics, computational biology, bioinformatics, computer science, or a related field* High experience in CDISC-compliant statistical programming in SAS, with the aim of increasing efficiency.* Strong understanding of CDISC standards, including SDTMIG and ADaMIG.* Demonstrated experience in developing efficacy and safety TFLs.* Good understanding of clinical trial processes, clinical data structures, and statistical reporting requirements.* Ability to work independently while managing multiple priorities and deadlines.* Strong problem-solving, organizational, and communication skills.* Comfortable working across multiple phases of clinical development and able to shift gears quickly.* Strong understanding of clinical trial design, data analysis, and regulatory requirements.* Excellent problem-solving skills and attention to detail. **Preferred Qualifications:** * Experience of working with international teams remotely is a plus.* Statistical background or knowledge is a plus.* Experience with submission-related deliverables such as Define.xml, SDRG, ADRG, P21 reports or related documentation is a plus* Experience with integrated summaries of safety (ISS) and efficacy (ISE) is a plus. **Experience:*** Minimum of 7+ years of relevant experience in clinical statistics in industry (pharmaceuticals, biotechnology, or CRO).
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