ClinChoice

Lead programming activities for oncology clinical trials, ensuring regulatory compliance and quality of deliverables. | 8-12+ years of SAS programming experience, expertise in oncology studies, and familiarity with regulatory submissions. | 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 Principal Statistical Programmer Consultant to join one of our clients. The Principal Statistical Programmer will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors. This role requires advanced expertise in SAS, familiarity with R, deep knowledge of CDISC standards, and strong experience working on oncology studies and regulatory submissions. Key Responsibilities Technical Leadership Lead programming activities for oncology clinical trials across multiple studies. Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines. Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions. Provide SAS programming expertise to support complex data derivations and analyses. Review and ensure traceability, consistency, and quality of all programming deliverables. Project & Study Management Act as programming lead for assigned studies, managing timelines and deliverables. Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs. Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to Kite’s programming standards. Support integrated analyses including ISS/ISE. Regulatory & Submission Support Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides. Ensure all programming meets regulatory requirements (FDA, EMA, PMDA). Contribute to responses for regulatory queries and data requests. Required Qualifications Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field. 8–12+ years of statistical programming experience in pharma/biotech or CRO. Expert-level proficiency in SAS. Strong understanding of CDISC SDTM and ADaM standards. Significant experience supporting oncology clinical trials (hematologic or solid tumors). Experience supporting regulatory submissions and preparing submission-ready outputs. Excellent communication skills and ability to collaborate cross-functionally. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #Principal#Contract

Lead programming activities for clinical studies, manage teams and vendors, and support regulatory submissions. | 8-12+ years in clinical programming, proficiency in SAS and R, expertise in CDISC standards, experience with regulatory submissions, leadership skills. | 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 currently recruiting for a Associate Director of Statistical programming, Hybrid to join our client’s team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment. This is a Hybrid role, with a preference for candidates who can travel to the client’s location - Waltham, MA. We are seeking an experienced Associate Director of Programming to lead programming activities, build scalable processes, and ensure high-quality deliverables for regulatory submissions. Role Overview The Associate Director, Programming will serve as a strategic and technical leader within the Biometrics team. This role will oversee clinical programming deliverables across studies, manage internal and external resources, and drive the adoption of modern programming tools and standards. The ideal candidate has strong expertise in SAS and/or R, deep knowledge of CDISC standards, and experience supporting regulatory submissions. Key Responsibilities Leadership & Strategy • Lead programming strategy across multiple clinical studies and development programs. • Oversee and manage internal programmers and external vendors/CRO partners. • Establish and maintain programming standards, processes, and best practices. • Support planning, timelines, and resourcing for all programming activities. Technical & Delivery • Provide oversight and hands-on support for the development and validation of: • SDTM, ADaM datasets • TLFs (Tables, Listings, Figures) • Integrated datasets for ISS/ISE • Ensure all deliverables meet regulatory, statistical, and quality requirements. • Guide the implementation of programming workflows using SAS and/or R. • Drive automation, reproducibility, and process efficiency within the programming team. Cross-Functional Collaboration • Partner closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams. • Serve as a key programming representative in study team meetings. • Support regulatory submissions, including eCTD-ready deliverables, reviewer guides, and traceability documents. Qualification Required: • Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field. • 8–12+ years of experience in clinical programming within pharma/biotech or CRO. • Strong proficiency in SAS, with experience in R being a strong plus. • Expert-level knowledge of CDISC standards (SDTM, ADaM). • Experience managing or overseeing programming teams and external vendors. • Proven track record supporting regulatory submissions (FDA, EMA, PMDA, etc.). • Excellent communication, leadership, and project management skills. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #Associate Director#Permanent

Manage RWE project portfolio, ensure documentation accuracy, drive process improvements, and support compliance and training. | Proven project management expertise, proficiency in Wrike or similar tools, strong documentation skills, and experience in change management and coordination. | Note: The job is a remote job and is open to candidates in USA. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. They are seeking a RWE Portfolio/Project Manager Consultant to manage the RWE project portfolio, ensure accurate documentation, and drive process improvements while working independently with clients. Responsibilities • Manage the RWE project portfolio in Wrike, ensuring project information is accurately captured and maintained from intake through close-out. • Monitor portfolio documentation for accuracy and completeness (e.g., status updates, milestones), generate monthly reports for leadership, and provide ad hoc reporting as needed. • Serve as a Wrike ambassador, offering expert guidance and support to ensure effective use of the platform across the team. • Drive and advocate for process improvements by surfacing feedback, identifying opportunities for efficiency, and championing changes that enhance portfolio management. • Manage the Methods Review Board (MRB) process, including initiating reviews, coordinating timelines with chairs and reviewers, and ensuring documentation is complete and archived. • Oversee compliance for RRAMS by tracking project entries, monitoring adherence, and ensuring business compliance for MRB-related projects. • Support the development, revision, and delivery of procedural trainings, SOPs, and documentation. • Coordinate team meetings and events, including face-to-face meetings and Lunch & Learn sessions, ensuring smooth planning and execution. • Provide additional coordination and administrative support as needed. Skills • Proven expertise in project and portfolio management, with strong documentation skills and knowledge of best practices. • Proficiency in Wrike or similar project management tools; advanced skills in Microsoft Office Suite. • Experience with compliance, quality processes, and administrative management. • Strong communication skills with the ability to influence stakeholders and drive change across teams. • Demonstrated experience in change management, including surfacing feedback, championing process improvements, and leading adoption of new practices. • Experience in event planning and coordination is a plus. Company Overview • ClinChoice is a Reaserch and Deveiopment platform, It develops a innovative drugs and devices. It was founded in 1995, and is headquartered in Shanghai, Shanghai, CHN, with a workforce of 1001-5000 employees. Its website is https://www.clinchoice.com.cn. Company H1B Sponsorship • ClinChoice has a track record of offering H1B sponsorships, with 18 in 2025, 28 in 2024, 21 in 2023, 25 in 2022, 35 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role.