Sr Manager, Statistical Programming

Experteer Overview In this role you will lead statistical programming efforts for clinical studies, guiding both hands-on programming and oversight of outsourced work. You’ll ensure regulatory-aligned processes, high-quality deliverables, and timely results, collaborating with statisticians and CROs. You’ll drive the development of SDTMs, ADaM datasets, and TLFs while advancing programming excellence across the study team. This position offers impact through shaping data for submissions and publications, in a fast-paced development setting. Compensation / Benefits * Provide programming support for the development or QC of SDTMs, ADaM specifications, ADaM datasets, and TLFs * Manage statistical programming activities for a clinical study (CSR, iDMC, ad-hoc analyses, publications) * Ensure quality, traceability, reproducibility, and timeliness of programming deliverables to meet regulatory requirements * Independently implement routine and non-standard analysis algorithms for assigned projects or studies * Collaborate with statisticians, local and CRO programmers to define and implement analysis requirements and provide sponsor oversight * Deliver exemplary performance and solve complex technical problems to inspire other programmers * Coordinate with the clinical study team to ensure efficient collaboration * Ensure programming systems and deliverables comply with regulatory guidelines (ICH E3, 21 CFR Part 11, eCTD, CDISC SDTM/ADaM) * Keep abreast of new techniques and support implementation in practice * Ensure all relevant programming documents are filed in Trial Master File * Contribute to standard formats and templates for programming documentation * Follow programming SOPs and maintain awareness of Servier SOPs * Assist the project lead in planning and tracking study activities and timelines Tasks * Masters in Statistics, Engineering, or relevant field with at least 5 years in statistical programming or biostatistics in pharma/biotechnology * Clinical development experience preferred * Experience with statistical programming in Oncology desirable * Proficient in SAS * Good knowledge of CDISC ADaM and SDTM * Strong knowledge of regulatory and data submission guidelines * Self-directed and technically strong; capable of managing programmers at study level * Strong study management, negotiation, and issue resolution skills * Ability to organize team work, prioritize tasks, and manage time effectively * Ability to educate internal and external interfaces (CROs and contractors) on statistical programming processes and regulatory requirements Key requirements * medical, dental, vision * flexible time off (unlimited sick time and flex time) * 401(k) * life and disability insurance * short-term and long-term incentive programs * competitive benefits package

inspire or studies * Collaborate with statisticians, local and CRO programmers to define and implement analysis requirements and provide sponsor oversight * Deliver exemplary performance and solve complex technical problems to inspire other programmers * Coordinate with the clinical study team to ensure efficient collaboration * Ensure programming systems and deliverables comply with regulatory guidelines (ICH E3, 21 CFR Part 11, eCTD, CDISC SDTM/ADaM) * Keep abreast of new techniques and support implementation in practice * Ensure all relevant programming documents are filed in Trial Master File * Contribute to standard formats and templates for programming documentation * Follow programming SOPs and maintain awareness of Servier SOPs * Assist the project lead in planning and tracking study activities and timelines Tasks * Masters in Statistics, Engineering, or relevant field with at least 5 years in statistical programming or biostatistics in pharma/biotechnology * Clinical development experience preferred * Experience with statistical programming in Oncology desirable * Proficient in SAS * Good knowledge of CDISC ADaM and SDTM * Strong knowledge of regulatory and data submission guidelines * Self-directed and technically strong; capable of managing programmers at study level * Strong study management, negotiation, and issue resolution skills * Ability to organize team work, prioritize tasks, and manage time effectively * Ability to educate internal and external interfaces (CROs and contractors) on statistical programming processes and regulatory requirements Key requirements * medical, dental, vision * flexible time off (unlimited sick time and flex time) * 401(k) * life and disability insurance * short-term and long-term incentive programs * competitive benefits package