{"company":" Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through , a full-service oncology CRO, and multi-therapeutic global functional and CRO services through . The companys customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit . The Machine Learning Engineer is a pivotal contributor responsible for designing and implementing cutting-edge machine learning solutions with a focus on generative AI technologies. You will drive the development and deployment of advanced models and pipelines that enable the creation of AI-driven applications and enhance organizational decision-making capabilities. Additionally, you will support data engineering initiatives to enable utilization of data across the organization. Collaborating closely with internal and external stakeholders, you will translate complex requirements into innovative solutions that advance Catalysts AI strategies while ensuring alignment with broader enterprise goals. ","role":" Position Responsibilities/ Accountabilities: Design, build, and optimize machine learning workflows, with a focus on generative AI models such as large language models (LLMs) and diffusion-based architectures. Develop and deploy scalable machine learning pipelines using frameworks like TensorFlow, PyTorch, and Databricks MLflow. Develop AI solutions using tools like Azure AI/Copilot Studio and Databricks AI Builder. Lead the creation of domain-specific generative AI models, ensuring ethical AI practices and bias mitigation throughout the model lifecycle. Design, build, and maintain scalable data pipelines with Delta Live Tables for model integration into enterprise applications. Enhance and expand CI/CD strategies for automated testing, model monitoring, and continuous delivery of ML artifacts. Manage data preprocessing, feature engineering, and synthetic data generation for machine learning use cases. Collaborate with cross-functional teams to align AI-driven solutions with business goals and ensure high availability for end-to-end systems. Provide technical expertise in the exploration of novel generative AI methods, tools, and frameworks. Support team members in understanding data science and AI best practices, encouraging a culture of innovation and continuous learning. Represent AI as a key member of the Data & Architecture Review Committee. Position Qualification Requirements : Education : B.S. or M.S. Computer Science, Engineering, Economics, Mathematics, related field, or relevant experience. Experience: 5+ years of experience in machine learning engineering, including model development and deployment. Hands-on experience with generative AI models (e.g., GPT, GANs, VAEs) and frameworks like PyTorch or TensorFlow. 5+ years of experience with cloud computing technologies (Azure, AWS, GCP), especially AI and ML services. Proficiency in developing data pipelines and integrating ML models into production environments. Expertise in model evaluation and monitoring, including techniques for explainability and fairness in AI. Experience collaborating with DevOps and MLOps teams to ensure scalability and reliability of AI solutions. Familiarity with project management tools such as JIRA. Required Skills: Advanced proficiency in Python or PySpark for ML applications. Deep understanding of generative AI principles, model architecture, and training methodologies. Expertise in large-scale data processing and engineering using Spark, Kafka, and Databricks. Proficiency with big data technologies and data structures like delta, parquet, YAML, JSON, and HTML. Strong knowledge of cloud-based AI platforms (e.g. Databricks, Azure ML, etc). Solid understanding of machine learning pipelines and MLOps practices. Exceptional problem-solving and analytical skills. Ability to manage priorities and workflow effectively. Proven ability to handle multiple projects and meet tight deadlines. Strong interpersonal skills with an ability to work collaboratively across teams. Commitment to excellence and high standards. Creative, flexible, and innovative team player. Ability to work independently and as part of various committees and teams. Nice to Have: Data Engineering experience, including Webhooks, API, ELT/ETL, rETL, Data Lakehouse Architecture, and Event-Driven Architectures. Familiarity with deep learning frameworks for generative AI (e.g., Hugging Face Transformers). Knowledge of synthetic data generation techniques and tools. Experience with data visualization tools (e.g., Tableau, Power BI) for AI model interpretability. Familiarity with ethical AI principles, including explainability and bias reduction strategies. Experience with containerization and orchestration tools like Docker and Kubernetes. Background or familiarity with clinical trials or pharmaceutical development. Working Hours Everyday: 1:30 PM - 9:00 PM IST OR Monday, Wednesday, Friday: 2:30 PM - 10:30 PM IST Tuesday, Thursday: 9:00 AM - 5:00 PM IST Note: Working hours may vary based on individual seniority, business demand, and ability to work independently. This will be evaluated on a case-by-case basis. "},"
Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com. Job Description The Senior Clinical Data Coordinator (Sr. CDC) is a key member of the Development Operations, Data Management Team. The Senior Clinical Data Coordinator will provide data management support for all assigned studies. The Sr. CDC prepares, validates, processes, and maintains clinical data in support of submissions to international regulatory agencies or publication of manuscripts through the use of EDC and SAS software. Assist in the development of edit specifications, based on any available global medical standards, therapeutic area standards, and the protocol, used to clean the study. Performs user acceptance testing (UAT) on eCRF build and edit specifications. Creates supporting DM process documentation to LDM and/or performs peer review of documentation, including updating documentation. Support the coding schedule defined in the data management plan. Collaborate with data coding specialists on a regular basis to guarantee timely coding. Supports/maintains quarterly coding review cycles. Performs manual data listing reviews and submits queries as appropriate. Assist with and/or performs user acceptance testing of lab data standards. Evaluates quality of lab data entry and addresses inconsistencies with sites and CRAs as applicable. Assists in the SAE reconciliation process. This may include coordination with medical experts and Global Drug Safety. Follow up on discrepancies and resolve so both databases are consistent. Applies criteria for subject stage gate of No More Issues (NMI). Also, must coordinate and review medical and statistical queries and certify they are adequately resolved. Assist in the development of a blind review report and conducting a blind review meeting to assign patient validity. Assist in developing and generating study report listings according to ICH and if present company guidelines. Coordinate the query management system functions. Perform the final patient review and database lock activities. Assist in coordinating the processing of scheduled data transfers (PK/PD data, imaging data, Laboratory data) from external vendors and performs relevant review/reconciliation. Review query responses and ensure data quality. Reviews Site responses to queries and evaluates the necessity of a re-query. If applicable, communications with Site Coordinators are performed for resolution. Attends and may lead internal and external team meetings. Reviews and/or provides meeting minutes. Supports training and development of Clinical Data Coordinators. Assists with eCRF design. May be required to develop the eCRF and/or provide peer review. May serve as a back up to the LDM for internal and external study teams. N/A Education : Bachelor’s degree in related discipline and three years of related experience; or high school diploma and four years of related experience. Experience : See “Education.” Required Certifications : N/A Required Skills Proficient with Microsoft Office Suite. Excellent written and oral communication skills. Excellent presentation skills. Strong organizational, problem-solving, and analytical skills. Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities. Proven ability to handle multiple projects and meet deadlines. Strong interpersonal skills. Ability to deal effectively with a diversity of individuals at all organizational levels. Commitment to excellence and high standards. Creative, flexible, and innovative team player. Ability to work independently and as a member of various teams and committees. Good judgement with the ability to make timely and sound decisions. Ability to be discreet with sensitive company information.
{"company":" Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through , a full-service oncology CRO, and multi-therapeutic global functional and CRO services through . The companys customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit . ","role":" Job Description The Senior Clinical Data Coordinator (Sr. CDC) is a key member of the Development Operations, Data Management Team. The Senior Clinical Data Coordinator will provide data management support for all assigned studies. The Sr. CDC prepares, validates, processes, and maintains clinical data in support of submissions to international regulatory agencies or publication of manuscripts through the use of EDC and SAS software. Assist in the development of edit specifications, based on any available global medical standards, therapeutic area standards, and the protocol, used to clean the study. Performs user acceptance testing (UAT) on eCRF build and edit specifications. Creates supporting DM process documentation to LDM and/or performs peer review of documentation, including updating documentation. Support the coding schedule defined in the data management plan. Collaborate with data coding specialists on a regular basis to guarantee timely coding. Supports/maintains quarterly coding review cycles. Performs manual data listing reviews and submits queries as appropriate. Assist with and/or performs user acceptance testing of lab data standards. Evaluates quality of lab data entry and addresses inconsistencies with sites and CRAs as applicable. Assists in the SAE reconciliation process. This may include coordination with medical experts and Global Drug Safety. Follow up on discrepancies and resolve so both databases are consistent. Applies criteria for subject stage gate of No More Issues (NMI). Also, must coordinate and review medical and statistical queries and certify they are adequately resolved. Assist in the development of a blind review report and conducting a blind review meeting to assign patient validity. Assist in developing and generating study report listings according to ICH and if present company guidelines. Coordinate the query management system functions. Perform the final patient review and database lock activities. Assist in coordinating the processing of scheduled data transfers (PK/PD data, imaging data, Laboratory data) from external vendors and performs relevant review/reconciliation. Review query responses and ensure data quality. Reviews Site responses to queries and evaluates the necessity of a re-query. If applicable, communications with Site Coordinators are performed for resolution. Attends and may lead internal and external team meetings. Reviews and/or provides meeting minutes. Supports training and development of Clinical Data Coordinators. Assists with eCRF design. May be required to develop the eCRF and/or provide peer review. May serve as a back up to the LDM for internal and external study teams. N/A Education : Bachelor s degree in related discipline and three years of related experience; or high school diploma and four years of related experience. Experience : See Education. Required Certifications : N/A Required Skills : Proficient with Microsoft Office Suite. Excellent written and oral communication skills. Excellent presentation skills. Strong organizational, problem-solving, and analytical skills. Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities. Proven ability to handle multiple projects and meet deadlines. Strong interpersonal skills. Ability to deal effectively with a diversity of individuals at all organizational levels. Commitment to excellence and high standards. Creative, flexible, and innovative team player. Ability to work independently and as a member of various teams and committees. Good judgement with the ability to make timely and sound decisions. Ability to be discreet with sensitive company information. "},"
The Senior Clinical Data Coordinator (Sr. CDC) is a key member of the Development Operations, Data Management Team at Catalyst Clinical Research. In this role, you will provide data management support for all assigned studies. Your responsibilities will include preparing, validating, processing, and maintaining clinical data to support submissions to international regulatory agencies or publication of manuscripts. You will utilize EDC and SAS software for these tasks. As a Senior Clinical Data Coordinator, you will play a crucial role in the development of edit specifications based on global medical standards, therapeutic area standards, and study protocols to ensure data accuracy. You will also be involved in user acceptance testing on eCRF builds and edit specifications, as well as creating and updating supporting DM process documentation. Collaboration with data coding specialists is essential to ensure timely and accurate coding schedules. You will support quarterly coding review cycles, perform manual data listing reviews, and submit queries as necessary. Additionally, you will assist with user acceptance testing of lab data standards and evaluate the quality of lab data entry, addressing inconsistencies with sites and CRAs. Your role will also involve assisting in the SAE reconciliation process, coordinating with medical experts and Global Drug Safety to resolve discrepancies between databases. You will apply criteria for subject stage gate of No More Issues (NMI) and coordinate the resolution of medical and statistical queries. Furthermore, you will contribute to the development of blind review reports, conduct blind review meetings, and generate study report listings according to ICH and company guidelines. Coordinating query management system functions, final patient review, and database lock activities will also be part of your responsibilities. As a Senior Clinical Data Coordinator, you will support the processing of scheduled data transfers from external vendors, review query responses, ensure data quality, and evaluate site responses to queries. Attending and leading internal and external team meetings, providing meeting minutes, training Clinical Data Coordinators, and assisting with eCRF design are additional aspects of this role. To qualify for this position, you should have a Bachelor's degree in a related discipline and three years of related experience, or a high school diploma and four years of related experience. Proficiency in Microsoft Office Suite, excellent communication and presentation skills, strong organizational and analytical abilities, and the capacity to manage priorities and meet deadlines are essential for success in this role. Additionally, you should be a creative, flexible team player with strong interpersonal skills and the ability to work independently and collaboratively within diverse teams. Your commitment to excellence, sound decision-making skills, and discretion with sensitive information are highly valued at Catalyst Clinical Research.,
Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com. As a Principal Statistical Programmer you will be a key member of the Development Operations, Statistical Programming Team. You will program routine and customized data displays, (including listings, tables, and graphics) in accordance with approved Statistical Analysis Plan and shell displays. Additionally, you write CDISC compliant SDTM specifications and program CDISC compliant SDTM and ADaM domains. Code is to be written using SAS, SAS procedures, or standardized macros. You will assume a leadership role on multiple complex projects, direct and/or mentor programmers at more junior levels and/or participate in department and/or company initiatives. Position Responsibilities/Accountabilities Creation of safety and efficacy SAS datasets. Crea tion of SDTM and/or ADaM specifications. Creation of project specific macros and formats. Creation of CDISC compliant DEFINE, SDRG, ADRG. Serve as Statistical Programming subject matter expert (SME) as needed. Performing data checks as needed, to ensure integrity and correctness of data displays and to understand structure and content of data. Perform QC/validation of datasets, tables, listings, figures to verify the output with high efficiency. Establish, maintain, and strengthen professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel. Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations. Ensure the quality and integrity of data analysis and reporting. Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to management. Contribute to the development of functional-level standards, tools, and templates. Interact across operational areas as required. Interact with sponsor representatives as required. Education Position Qualifications/Requirements: Bachelor’s Degree in Computer Science/Mathematics or equivalent. Master’s degree preferred. (A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience.) Experience A minimum of 7 years of relevant work experience. Hands on Experience with CDISC/SDTM/ADaM Programming including but not limited to SAS: Data Step Manipulation, Merge, Sort, Transpose, Reporting (Proc Report), Comparison (Proc Compare), Error Checking (Log resolution), modeling, missing data handling approaches/procedures, figure development. Capable of conducting exploratory statistical analyses using statistical software packages. Experience developing custom SAS programs. Experience with P21 reporting and DEFINE, SDRG, ADRG development. Creation of annotated CRFs Previous experience in pharmaceutical research or CRO setting. Base or Advance SAS certification preferred. Required Certifications: N/A Required Skills Proficient with Microsoft Office 365 Suite (Outlook, Excel, Word, PowerPoint, Project preferred). Excellent verbal, written, and interpersonal skills. Knowledge of clinical trial study design. Ability to train staff on company macros and standards and programming approaches used on studies. Able to work independently on multiple, concurrent projects. A high degree of accuracy and attention to detail. Can attend study team meetings as needed. Excellent presentation skills. Strong organizational, problem-solving, and analytical skills. Ability to manage priorities and workflow for self and study teams. Ability to track, report, and escalate as needed on study level financials and resourcing needs. Ability to work on a SAS server environment using windows-based PC SAS. Versatility, flexibility, and a willingness to work within constantly changing priorities. Proven ability to handle multiple projects and meet deadlines. Ability to deal effectively with a diversity of individuals at all organizational levels. Commitment to excellence and high standards. Creative, flexible, and innovative team player. Good judgement with the ability to make timely and sound decisions. Ability to be discreet with sensitive company information. Ability to travel for meetings or training activities may be required. Applicants must be authorized to work for ANY employer in India. We are unable to sponsor or take over sponsorship of an employment visa.
Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com. Job Summary The SAS Programmer will be responsible for providing SAS programming support for the Statistics and Data Management functions for all clinical trials and regulatory submissions. The candidate will work closely with Biostatisticians and Data Managers to create SAS programs for independently validating selected tables, listings, and figures and to assist with data cleaning and query generation. This position will also serve as a contact for programming activities being performed. Key Activities Perform data manipulation techniques and advanced techniques (arrays, transpositions, complex merges, SQL, SDTM etc.) and generic macro use and development to enable listing, table, and graph generation. Involve in Statistical programming and validation of CDISC SDTM, Analysis Datasets (ADaM) and Tables, Listings, Graphs (TLG'S) Analyze information and develop innovative solutions to programming and data analysis challenges. Efficiently produce quality results under time constraints. Successfully coordinate multiple priorities. Based on experience, serve as the statistical programming lead on internal project teams and coordinate programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures. Assist internal project team in identifying project priorities and communicating such activities and associated timelines to departmental management Work independently to carry out assignments with occasional support from senior management. Ensure the efficiency, quality, and integrity of data reporting and project activities executed. Represent the department in client meetings/presentation and maintain a positive working relationship with sponsors, collaborating associate and vendor personnel. Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks. Contribute to on-going improvement of programming processes and methodology. Perform other related duties as required by the Department. Coach and advice junior programmers to identify problems and solutions Ability to adapt and adjust to changing priorities Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities, and deliverables. Ability to fulfill ad hoc requests and perform high level review on deliverables. Required Skills/ Experience MSc in Biostatistics, Statistics, Computer Science, or related field. 5-7 years of experience, to successfully perform the key responsibilities of the job Experience leading statistical programming activities in clinical research for 5 + years experienced candidates. SAS Certified Candidates preferred Good understanding of Clinical Trials and the various terminologies Experience leading statistical programming activities in clinical research Previous experience in pharmaceutical research or CRO setting Work within a team environment under extremely tight deadlines, and finish all TLGs ahead of schedule, despite severe data issues requiring multiple re-extractions and reruns Knowledge of one or more statistical software packages (SAS® preferred) used to perform statistical analyses Knowledge of CDISC services and hands on experience in developing SDTM datasets. Good verbal and written communication Positive attitude and willingness to learn and contribute to a team setting Demonstrates ability to successfully lead a single project.
Job Description Job Summary The SAS Programmer will be responsible for providing SAS programming support for the Statistics and Data Management functions for all clinical trials and regulatory submissions. The candidate will work closely with Biostatisticians and Data Managers to create SAS programs for independently validating selected tables, listings, and figures and to assist with data cleaning and query generation. This position will also serve as a contact for programming activities being performed. Key Activities: • Perform data manipulation techniques and advanced techniques (arrays, transpositions, complex merges, SQL, SDTM etc.) and generic macro use and development to enable listing, table, and graph generation. • Involve in Statistical programming and validation of CDISC SDTM, Analysis Datasets (ADaM) and Tables, Listings, Graphs (TLG'S) • Analyze information and develop innovative solutions to programming and data analysis challenges. • Efficiently produce quality results under time constraints. • Successfully coordinate multiple priorities. • Based on experience, serve as the statistical programming lead on internal project teams and coordinate programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures. • Assist internal project team in identifying project priorities and communicating such activities and associated timelines to departmental management • Work independently to carry out assignments with occasional support from senior management. • Ensure the efficiency, quality, and integrity of data reporting and project activities executed. • Represent the department in client meetings/presentation and maintain a positive working relationship with sponsors, collaborating associate and vendor personnel. • Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks. • Contribute to on-going improvement of programming processes and methodology. • Perform other related duties as required by the Department. • Coach and advice junior programmers to identify problems and solutions • Ability to adapt and adjust to changing priorities • Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities, and deliverables. • Ability to fulfill ad hoc requests and perform high level review on deliverables. Required Skills/ Experience: • MSc in Biostatistics, Statistics, Computer Science, or related field. • 5-7 years of experience, to successfully perform the key responsibilities of the job • Experience leading statistical programming activities in clinical research for 5 + years experienced candidates. • SAS Certified Candidates preferred • Good understanding of Clinical Trials and the various terminologies • Experience leading statistical programming activities in clinical research • Previous experience in pharmaceutical research or CRO setting • Work within a team environment under extremely tight deadlines, and finish all TLGs ahead of schedule, despite severe data issues requiring multiple re-extractions and reruns • Knowledge of one or more statistical software packages (SAS® preferred) used to perform statistical analyses • Knowledge of CDISC services and hands on experience in developing SDTM datasets. • Good verbal and written communication • Positive attitude and willingness to learn and contribute to a team setting • Demonstrates ability to successfully lead a single project.
Position Summary The Principal Statistical Programmer is a key member of the Development Operations, Statistical Programming Team. The Principal Statistical Programmer will program routine and customized data displays, (including listings, tables, and graphics) in accordance with approved Statistical Analysis Plan and shell displays. Additionally, the Principal Statistical Programmer will write CDISC compliant SDTM specifications and program CDISC compliant SDTM and ADaM domains. Code is to be written using SAS, SAS procedures, or standardized macros. The Principal Programmer will assume a leadership role on multiple complex projects, direct and/or mentor programmers at more junior levels and/or participate in department and/or company initiatives. Position Responsibilities/Accountabilities Creation of safety and efficacy SAS datasets. Creation of SDTM and/or ADaM specifications. Creation of project specific macros and formats. Creation of CDISC compliant DEFINE, SDRG, ADRG. Serve as Statistical Programming subject matter expert (SME) as needed. Performing data checks as needed, to ensure integrity and correctness of data displays and to understand structure and content of data. Perform QC/validation of datasets, tables, listings, figures to verify the output with high efficiency. Establish, maintain, and strengthen professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel. Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations. Ensure the quality and integrity of data analysis and reporting. Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to management. Contribute to the development of functional-level standards, tools, and templates. Interact across operational areas as required. Interact with sponsor representatives as required. Position Qualification Requirements : Education : Bachelors Degree in Computer Science/Mathematics or equivalent. Masters degree preferred. (A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience.) Experience : A minimum of 7 years of relevant work experience. Hands on Experience with CDISC/SDTM/ADaM Programming including but not limited to SAS: Data Step Manipulation, Merge, Sort, Transpose, Reporting (Proc Report), Comparison (Proc Compare), Error Checking (Log resolution), modeling, missing data handling approaches/procedures, figure development. Capable of conducting exploratory statistical analyses using statistical software packages. Experience developing custom SAS programs. Experience with P21 reporting and DEFINE, SDRG, ADRG development. Creation of annotated CRFs Previous experience in pharmaceutical research or CRO setting. Base or Advance SAS certification preferred. Required Certifications : N/A Required Skills : Proficient with Microsoft Office 365 Suite (Outlook, Excel, Word, PowerPoint, Project preferred). Excellent verbal, written, and interpersonal skills. Knowledge of clinical trial study design. Ability to train staff on company macros and standards and programming approaches used on studies. Able to work independently on multiple, concurrent projects. A high degree of accuracy and attention to detail. Can attend study team meetings as needed. Excellent presentation skills. Strong organizational, problem-solving, and analytical skills. Ability to manage priorities and workflow for self and study teams. Ability to track, report, and escalate as needed on study level financials and resourcing needs. Ability to work on a SAS server environment using windows-based PC SAS. Versatility, flexibility, and a willingness to work within constantly changing priorities. Proven ability to handle multiple projects and meet deadlines. Ability to deal effectively with a diversity of individuals at all organizational levels. Commitment to excellence and high standards. Creative, flexible, and innovative team player. Good judgement with the ability to make timely and sound decisions. Ability to be discreet with sensitive company information. Ability to travel for meetings or training activities may be required
As a Principal Statistical Programmer you will be a key member of the Development Operations, Statistical Programming Team. You will program routine and customized data displays, (including listings, tables, and graphics) in accordance with approved Statistical Analysis Plan and shell displays. Additionally, you write CDISC compliant SDTM specifications and program CDISC compliant SDTM and ADaM domains. Code is to be written using SAS, SAS procedures, or standardized macros. You will assume a leadership role on multiple complex projects, direct and/or mentor programmers at more junior levels and/or participate in department and/or company initiatives. Position Responsibilities / Accountabilities: Creation of safety and efficacy SAS datasets. Crea tion of SDTM and/or ADaM specifications. Creation of project specific macros and formats. Creation of CDISC compliant DEFINE, SDRG, ADRG. Serve as Statistical Programming subject matter expert (SME) as needed. Performing data checks as needed, to ensure integrity and correctness of data displays and to understand structure and content of data. Perform QC/validation of datasets, tables, listings, figures to verify the output with high efficiency. Establish, maintain, and strengthen professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel. Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations. Ensure the quality and integrity of data analysis and reporting. Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to management. Contribute to the development of functional-level standards, tools, and templates. Interact across operational areas as required. Interact with sponsor representatives as required. Position Qualifications/Requirements: Education: Bachelor s Degree in Computer Science/Mathematics or equivalent. Master s degree preferred. (A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience.)
The SAS Programmer will be responsible for providing SAS programming support for the Statistics and Data Management functions for all clinical trials and regulatory submissions. The candidate will work closely with Biostatisticians and Data Managers to create SAS programs for independently validating selected tables, listings, and figures and to assist with data cleaning and query generation. This position will also serve as a contact for programming activities being performed. Key Activities: Perform data manipulation techniques and advanced techniques (arrays, transpositions, complex merges, SQL, SDTM etc.) and generic macro use and development to enable listing, table, and graph generation. Involve in Statistical programming and validation of CDISC SDTM, Analysis Datasets (ADaM) and Tables, Listings, Graphs (TLGS) Analyze information and develop innovative solutions to programming and data analysis challenges. Efficiently produce quality results under time constraints. Successfully coordinate multiple priorities. Based on experience, serve as the statistical programming lead on internal project teams and coordinate programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures. Assist internal project team in identifying project priorities and communicating such activities and associated timelines to departmental management Work independently to carry out assignments with occasional support from senior management. Ensure the efficiency, quality, and integrity of data reporting and project activities executed. Represent the department in client meetings/presentation and maintain a positive working relationship with sponsors, collaborating associate and vendor personnel. Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks. Contribute to on-going improvement of programming processes and methodology. Perform other related duties as required by the Department. Coach and advice junior programmers to identify problems and solutions Ability to adapt and adjust to changing priorities Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities, and deliverables. Ability to fulfill ad hoc requests and perform high level review on deliverables. Required Skills/ Experience: MSc in Biostatistics, Statistics, Computer Science, or related field 5-7 years of experience, to successfully perform the key responsibilities of the job Experience leading statistical programming activities in clinical research for 5 + years experienced candidates SAS Certified Candidates preferred Good understanding of Clinical Trials and the various terminologies Experience leading statistical programming activities in clinical research Previous experience in pharmaceutical research or CRO setting Work within a team environment under extremely tight deadlines, and finish all TLGs ahead of schedule, despite severe data issues requiring multiple re-extractions and reruns Knowledge of one or more statistical software packages (SAS preferred) used to perform statistical analyses Knowledge of CDISC services and hands on experience in developing SDTM datasets Good verbal and written communication Positive attitude and willingness to learn and contribute to a team setting Demonstrates ability to successfully lead a single project
Position Summary: The Principal Statistical Programmer is a key member of the Development Operations, Statistical Programming Team. The Principal Statistical Programmer will program routine and customized data displays, (including listings, tables, and graphics) in accordance with approved Statistical Analysis Plan and shell displays. Additionally, the Principal Statistical Programmer will write CDISC compliant SDTM specifications and program CDISC compliant SDTM and ADaM domains. Code is to be written using SAS, SAS procedures, or standardized macros. The Principal Programmer will assume a leadership role on multiple complex projects, direct and/or mentor programmers at more junior levels and/or participate in department and/or company initiatives. Position Responsibilities/Accountabilities: • Creation of safety and efficacy SAS datasets. • Creation of SDTM and/or ADaM specifications. •Creation of project specific macros and formats. •Creation of CDISC compliant DEFINE, SDRG, ADRG. •Serve as Statistical Programming subject matter expert (SME) as needed. •Performing data checks as needed, to ensure integrity and correctness of data displays and to understand structure and content of data. •Perform QC/validation of datasets, tables, listings, figures to verify the output with high efficiency. •Establish, maintain, and strengthen professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel. •Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations. •Ensure the quality and integrity of data analysis and reporting. •Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to management. •Contribute to the development of functional-level standards, tools, and templates. •Interact across operational areas as required. •Interact with sponsor representatives as required. Position Qualification Requirements: Education: • Bachelor’s Degree in Computer Science/Mathematics or equivalent. Master’s degree preferred. (A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience.) Experience: •A minimum of 7 years of relevant work experience. •Hands on Experience with CDISC/SDTM/ADaM Programming including but not limited to SAS: Data Step Manipulation, Merge, Sort, Transpose, Reporting (Proc Report), Comparison (Proc Compare), Error Checking (Log resolution), modeling, missing data handling approaches/procedures, figure development. •Capable of conducting exploratory statistical analyses using statistical software packages. •Experience developing custom SAS programs. •Experience with P21 reporting and DEFINE, SDRG, ADRG development. •Creation of annotated CRFs •Previous experience in pharmaceutical research or CRO setting •Base or Advance SAS certification preferred. Required Certifications: N/A Required Skills: •Proficient with Microsoft Office 365 Suite (Outlook, Excel, Word, PowerPoint, Project preferred). •Excellent verbal, written, and interpersonal skills. •Knowledge of clinical trial study design. •Ability to train staff on company macros and standards and programming approaches used on studies. •Able to work independently on multiple, concurrent projects. •A high degree of accuracy and attention to detail. •Can attend study team meetings as needed. •Excellent presentation skills. •Strong organizational, problem-solving, and analytical skills. •Ability to manage priorities and workflow for self and study teams. •Ability to track, report, and escalate as needed on study level financials and resourcing needs. •Ability to work on a SAS server environment using windows-based PC SAS. •Versatility, flexibility, and a willingness to work within constantly changing priorities. •Proven ability to handle multiple projects and meet deadlines. •Ability to deal effectively with a diversity of individuals at all organizational levels. •Commitment to excellence and high standards. •Creative, flexible, and innovative team player. •Good judgement with the ability to make timely and sound decisions. •Ability to be discreet with sensitive company information. •Ability to travel for meetings or training activities may be required.
As a SAS Programmer at Catalyst Clinical Research, you will play a crucial role in providing SAS programming support for Statistics and Data Management functions related to clinical trials and regulatory submissions. Your responsibilities will involve collaborating closely with Biostatisticians and Data Managers to develop SAS programs for validating tables, listings, and figures, as well as assisting with data cleaning and query generation. Additionally, you will serve as a contact for programming activities within the organization. Key Responsibilities: - Perform data manipulation techniques and advanced programming techniques such as arrays, transpositions, complex merges, SQL, SDTM, etc., and develop generic macros for generating listings, tables, and graphs. - Engage in statistical programming and validation of CDISC SDTM, Analysis Datasets (ADaM), and Tables, Listings, Graphs (TLGs). - Analyze information to devise innovative solutions for programming and data analysis challenges. - Produce high-quality results efficiently within specified time constraints. - Coordinate multiple priorities successfully and lead statistical programming activities on internal project teams. - Assist in identifying project priorities, communicating timelines, and ensuring the efficiency and quality of data reporting. - Represent the department in client meetings/presentations and maintain positive relationships with sponsors and collaborators. - Contribute to the ongoing improvement of programming processes and methodologies. - Provide guidance and advice to junior programmers, adapt to changing priorities, and fulfill ad hoc requests while performing high-level reviews on deliverables. Qualifications Required: - MSc in Biostatistics, Statistics, Computer Science, or a related field. - 5-7 years of experience in leading statistical programming activities in clinical research. - Preferred certification as a SAS Certified Candidate. - Good understanding of Clinical Trials and relevant terminologies. - Previous experience in pharmaceutical research or CRO setting. - Proficiency in statistical software packages, with a preference for SAS, and hands-on experience in developing SDTM datasets. - Strong verbal and written communication skills. - Positive attitude, willingness to learn, contribute to a team setting, and ability to successfully lead a single project. Visit CatalystCR.com to learn more about Catalyst Clinical Research and how your role as a SAS Programmer contributes to advancing clinical studies.,