Manager, Statistical Programming

Job not on LinkedIn

🔥 12 hours ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

👻 Ghost score 10%

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Logo of Cencora

Cencora

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• Independently develop, validate, and maintain SAS/R programs • Develop analysis datasets and produce TFLs for clinical studies and regulatory submission deliverables • Develop and validate SDTM- and ADaM-compliant datasets according to specifications and study requirements • Program, generate, and quality-check efficacy and safety TFLs following SAPs, mock shells, and internal standards • Perform SAS and R statistical programming • Contribute to programming deliverables across multiple studies or projects • Collaborate with Biostatistics, Data Management, Clinical, and other cross-functional teams to resolve data issues and support study objectives • Create and maintain programming documentation, specifications, and standard processes • Contribute to process improvements, standardization, and reusable programming tools such as macros and templates • Ensure timely delivery of high-quality programming outputs in a clinical development environment • Provide technical guidance and day-to-day support to junior programmers or peers • Participate in code review, debugging, and validation activities • Validate and debug code written by other team members • Maintain project quality and timeliness

🎯 Requirements

• 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 • 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 • Minimum of 7+ years of relevant experience in clinical statistics in industry (pharmaceuticals, biotechnology, or CRO) • Preferred: Experience of working with international teams remotely • Preferred: Statistical background or knowledge • Preferred: Experience with submission-related deliverables such as Define.xml, SDRG, ADRG, P21 reports or related documentation • Preferred: Experience with integrated summaries of safety (ISS) and efficacy (ISE)

🏖️ Benefits

• Benefit offerings outside the US may vary by country and will be aligned to local market practice • Equal employment opportunity and non-discriminatory recruiting, training, compensation, benefits, promotions and transfers • Reasonable accommodations during the employment process for individuals with disabilities

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