Senior Statistical Programmer/Analyst Consultant - (remote in US)

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. We are seeking an experienced Senior Statistical Programmer with strong expertise in clinical trial programming and a solid background in oncology . The successful candidate will be capable of independently leading statistical programming activities across clinical studies, partnering closely with statisticians, clinical teams, and other cross-functional stakeholders. This role requires strong technical expertise in SAS programming, CDISC standards, and clinical trial reporting , along with the ability to take ownership of programming deliverables and provide guidance to junior team members. Key Responsibilities Lead statistical programming activities for clinical studies within the oncology therapeutic area , from study start-up through database lock, analysis, and reporting. Develop, review, and maintain high-quality SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs) . Lead programming activities for interim and final analyses, including complex efficacy and safety analyses. Work closely with Biostatisticians to understand statistical analysis plans, programming specifications, and study requirements. Develop and review programming specifications and ensure consistency with study protocols, SAPs, and statistical methodology. Support the creation and validation of CDISC-compliant SDTM and ADaM datasets . Generate and validate TLFs fo

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. We are seeking an experienced Senior Statistical Programmer with hands-on experience in Gene Therapy clinical trials to lead study-level statistical programming activities. The ideal candidate will have strong SAS programming expertise, a solid understanding of clinical trial data and regulatory requirements, and the ability to independently manage programming deliverables in collaboration with Biostatisticians and cross-functional teams. Experience in Gene Therapy clinical development is essential. Experience in Oncology or Internal Medicine is also valuable. Key Responsibilities Lead statistical programming activities for Gene Therapy clinical trials from study start-up through database lock, analysis, and reporting. Develop, review, and validate SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs). Collaborate with Biostatisticians to interpret study protocols, Statistical Analysis Plans (SAPs), and programming specifications. Develop and validate clinical datasets and statistical outputs for safety and efficacy analyses. Support interim and final analyses, database lock activities, and Clinical Study Report preparation. Ensure programming deliverables comply with CDISC standards and applicable regulatory requirements. Perform independent validation and quality control of datasets, TLFs, and other programming outputs. S

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior Real World Data Programmer Consultant to join one of our clients. ClinChoice is a leading global CRO, dedicated to supporting clinical trials and real-world evidence research with a focus on exceptional quality, career development, and a supportive culture. As we expand our presence and offerings, we’re looking for an experienced Senior Real World Data Analytics Consultant to join our dynamic team and lead analytical efforts across diverse therapeutic areas for a high-profile sponsor. Position Overview: We are seeking a Senior Real World Data (RWD) Analytics Consultant/Senior Real World Data Programmer Consultant to lead and oversee complex statistical analyses, provide high-level strategic recommendations, and guide junior analysts in the execution of observational research. This leadership position combines technical expertise with client-facing responsibilities, allowing the successful candidate to influence key decisions within our client’s RWE and cross-functional teams. The Senior Consultant will be responsible for ensuring the highest standards of data analysis and driving innovations that enhance our client’s research outcomes. Key Responsibilities: Lead the development and execution of statistical analysis plans (SAPs) for large-scale real-world evidence (RWE) studies. Work directly with cross-functional teams and senior stakeholders to design data-driven solutions that meet sponsor needs. Oversee and mentor junior analysts, reviewing work for accuracy, quality, and consistency. Provide guidance on the development and optimization of RWD analytics workflows. Establish and maintain strong, trusted relationships with client counterparts. Act as a key advisor, offering strategic insights based on

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Junior Statistical Programmer to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. The Junior Statistical Programmer is a delivery-focused role supporting clinical trial programming activities under the guidance and supervision of experienced Statistical Programmers and Programming Team Leaders. The individual will contribute to the development, validation, and maintenance of statistical programming deliverables and gain hands-on experience in clinical trial data and industry standards. The role requires a strong foundation in statistical programming, attention to detail, willingness to learn, and the ability to work effectively within a collaborative team environment. Responsibilities Programming for Clinical Trials Support the development and validation of datasets, tables, figures, and listings for clinical trials. Perform programming activities using SAS and/or R under appropriate guidance and review. Assist with processing and integrating data from internal and external sources. Support ad hoc analyses and programming activities for clinical development and other Research & Development functions. Assist with the development, review, and maintenance of programming specifications and documentation. Contribute to the development and review of SDTM and ADaM datasets and specifications . Support the preparation and review of Define-XML and other clinical trial documentation. Work closely with Senior Statistical Programmers, Biostatisticians, Data Managers, and other cross-functional team members. Electronic Submissions Support the programming and validation of CDISC-compliant datasets and deliverables for regulatory submissions. Assist with the preparation of supporting docume

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior Statistical Programmer to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking a highly skilled Senior Statistical Programmer to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! Main Job Tasks The Senior Statistical Programmer is a delivery-focused role responsible for leading and supporting aspects of the programming effort to deliver technical programming and information components of a project. The position requires strong technical skills, thorough knowledge of the industry, and demonstrated experience leading statistical programming activities and providing technical guidance to other programmers . The individual should be able to independently perform programming tasks, oversee programming deliverables, and effectively collaborate with cross-functional teams and external vendors. Responsibilities Programing for clinical trials: Program and validate derived datasets, tables, figures, listings. Process data from the external sources. Perform ad hoc exploratory analyses for publications and programming support other functions of Research and Development or other organizations. Oversee programing work/deliverables from CROs. Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages. Electronic submissions: Program

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X . About This Role Axsome Therapeutics is seeking a Manager/Senior Manager, Statistical Programming to provide programming support for multiple neurology compounds across all phases of development. This role will serve as lead programmer on assigned clinical trials, working closely with Biostatistics and Data Management. The Senior Manager, Statistical Programming will apply programming methodology to summary and analysis of clinical trial data, developing and utilizing SAS programs and macros to create and validate CDISC Study Data Tabulation Model (SDTM) conformed datasets, Analysis Dataset Model (ADaM) datasets, and Tables, Figures, and Listings (TFLs) as scoped in the Statistical Analysis Plan (SAP) for reporting purposes in the Clinical Study Report (CSR). This position will also manage Contract Research Organizations (CROs) providing programming support, and eSubmission package planning, execution, and quality checks of package components for