Senior Statistical Programmer - Nagpur - Planet Pharma

Description

We are looking for a highly experienced Clinical Statistical Programmer to independently lead programming activities across clinical studies. This role requires deep expertise in SDTM and ADaM dataset development, complex TLF generation, and regulatory submission support.

Key Responsibilities

• Design, develop, and validate SAS programs for SDTM, ADaM, and TLF outputs
• Produce submission-ready datasets and documentation, including Define.xml
• Review and interpret SAPs and data management plans to determine programming requirements
• Ensure deliverables comply with CDISC and regulatory standards
• Lead programming activities for assigned studies with minimal supervision
• Collaborate with cross-functional teams and external vendors on data standards and transfers
• Perform quality control and validation of datasets and outputs
• Identify and implement process improvements to enhance efficiency and consistency
• Contribute to continuous improvement initiatives within the programming function

Key Requirements:

• Bachelor's degree in Statistics, Biostatistics, Computer Science, Mathematics, or Life Sciences
• Minimum 8 years of clinical/statistical programming experience
• Strong hands-on experience creating SDTM and ADaM datasets
• Proven expertise in complex TLF programming
• In-depth knowledge of CDISC standards and regulatory submission requirements
• Experience preparing Define.xml and submission packages
• Proficiency in SAS; working knowledge of MS Office, XML, and Pinnacle 21
• Strong understanding of upstream data sources (eDC to SDTM workflows)
• Excellent analytical thinking and teamwork skills

About Planet Pharma:

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

Please click 'apply' or contact Charlotte Fagan (Recruitment Manager) at Planet Pharma for more information:

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