ClinChoice

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🔥 Sr Principal Statistical Programmer-Remote(Permanent role)

Posted 5 days ago

📍 United states

🧭 Full-Time

🔍 Clinical research

🔧 Requirements

Bachelor’s degree in computer science, statistics or related scientific disciplines with 10+ year clinical programming experience; Master’s degree in computer science, statistics or related disciplines with 9+ year of clinical programming experience;
Working knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
Good understanding of clinical drug development process
Detail oriented
Strong communication skills and coordination skills
Good leadership skills

💡 Responsibilities

Programming edit checks for Data Management with SAS.
Create tables, listings and figures for clinical study report.
Independently annotated blank CRF (acrf.pdf) with appropriate tools per FDA or CDISC guidelines.
Create or QC SDTM specifications and SDTM datasets.
Create or QC ADaM specifications and ADaM datasets.
Create or QC define.xml or define.pdf
Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf)
Serve as team leader for one/more Programming groups.
Independently coordinate and manage the preparation, execution, reporting and documentation of projects within a Programming group.
Manage and coordinate the integration of data across studies in support if ISS and ISE and electronic submission deliverables.
Following industry standards and be a mentor to other Programming leads or managers.
Manage programming team. Take initiatives and follow through to develop the Programming team. Dare to lead.
Be a role model for team members.

SAS EGData modelingData management

Posted 5 days ago

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🔥 REMOTE Principal Statistician- (Clinical)

Posted 12 days ago

📍 United Kingdom

🧭 Full-Time

🔍 Pharmaceutical

🔧 Requirements

MS or PhD in Statistics, Biostatistics or related field.
Strong oral and written communications skills, with ability to effectively communicate internally and with clients.
Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.

💡 Responsibilities

Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
Responsible for validity of analysis and explore alternative analysis strategies as needed.
Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians.
Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Data AnalysisSAS EGRDBMS

Posted 12 days ago

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🔥 REMOTE Senior Statistician- (Clinical)

Posted 16 days ago

📍 United Kingdom

🧭 Full-Time

🔍 Software Development

🔧 Requirements

MS or PhD in Statistics, Biostatistics, or related field.
Strong oral and written communication skills, with the ability to effectively communicate internally and with clients.
Demonstrated understanding and insight in statistics, drug development process, and relevant FDA regulations.
Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially the FDA.

💡 Responsibilities

Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
Responsible for assuring that data for statistical analyses are complete, accurate, and consistent.
Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
Responsible for the validity of the analysis and exploring alternative analysis strategies as needed.
Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
Responsible for the statistical methods section of the reports. Identifies and corrects common flaws in the interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and ensures project-wide consistency.
Effectively mentor peers with regard to statistical methodology and provide appropriate training to less experienced statisticians.
Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Project ManagementData AnalysisCommunication SkillsAnalytical SkillsMentoringWritten communicationMS OfficeData modeling

Posted 16 days ago

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🔥 Medical Writer

Posted 17 days ago

🔍 Medical Writing

🔧 Requirements

Minimum bachelor’s degree in any life sciences field
3-5 years of experience in medical writing, or any related field as applicable
Can work in a diverse team environment
Good analytical and comprehension skills
Proficient in time management and can work with minimal supervision
Proficient in oral and written English language
Proficient in Microsoft Office Suites (e.g. Word, Excel, PPT, SharePoint)

💡 Responsibilities

Responsible for authoring/reviewing/supporting regulatory documents (which include, but are not limited to, Systematic Literatures as support for Clinical Evaluation Reports, Post-Market Surveillance Reports and Premarket Approval Reports) as per client requirements using the assigned template within an assigned timeline.
Prepares, writes and edits literature review reports with the aim of synthesizing and analyzing clinical data from medical and scientific publications.
Participates in all phases of the systematic literature review process, from planning to execution, which include (aside from literature protocol and report writing) literature search, literature screening, literature appraisal and data extraction, and data analysis,
Ensures template and style guidelines are followed as appropriate,
Utilizes available software, such as literature processing tools, to perform specific tasks within the scope of work,
Communicates and collaborates with other team members and client stakeholders to ensure project timelines and quality standards of deliverables are met,
Demonstrates an understanding in assigned therapeutic areas, provides expertise in device technology, interprets clinical research methodology and study designs, ensures compliance with medical device regulations globally, and escalates any new or emerging risks

Posted 17 days ago

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🔥 Senior Statistical Programmer Consultant (remote)

Posted 18 days ago

📍 United States

🔍 Pharmaceutical or biotechnology

🔧 Requirements

Minimum of 10 years of SAS programming in the pharmaceutical or biotechnology industry with a BA/BS in computer science, statistics, math or MA/MS with 8 years of experience
Expertise in SAS programming language, report generation, and standards for programming and validation
Experience with CDISC data standards required
Experience as a senior statistical programmer level in a pharmaceutical or CRO working in a FDA regulated environment
Experience with Clinical Study Reports and NDA submission
Ability to work on multiple tasks simultaneously and meet project deadlines
Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment

💡 Responsibilities

Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings
Produce data listings, summary tables and graphics for interim and final analyses
Integrate data across studies within a project. Test, document, review and validate all programs according to department guidelines
Coordinate data transfer and/or programming standards with CROs and vendors. Validate analysis datasets and TFLs from vendors
Collaborate with other Biometrics functions for all activities related to analyses of clinical trial data
Responsible for execution of ad-hoc requests, manuscripts, posters, and presentations

Project ManagementSQLData AnalysisSAS EGAlgorithmsData StructuresCommunication SkillsAnalytical SkillsCI/CDProblem SolvingRESTful APIsAttention to detailDocumentationTeamworkCross-functional collaborationData visualizationData modelingData management

Posted 18 days ago

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🔥 Senior/Principal Biostatistician Consultant-Oncology (Remote in US)

Posted about 1 month ago

📍 United States

🔍 Pharmaceutical, CRO

🔧 Requirements

MS or PhD in Statistics, Biostatistics or related field.
Strong experience with Oncology TA.
Strong oral and written communications skills, with ability to effectively communicate internally and with clients.
Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.

💡 Responsibilities

Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
Responsible for validity of analysis and explore alternative analysis strategies as needed.
Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians.
Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Data AnalysisData modeling

Posted about 1 month ago

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🔥 Principal Statistical Programmer – Late Phase- Cardiovascular, Renal, and Metabolism (CVRM)-(REMOTE)

Posted about 1 month ago

📍 United States

🧭 Full-Time

🔍 Clinical Research

🔧 Requirements

Bachelor’s degree in Computer Science, Statistics, Mathematics, or related field
8+ years of SAS programming experience
4+ years in Cardiovascular, Renal, and Metabolism clinical trials
Knowledge of ICH and GCP
Understanding of late-phase clinical studies

💡 Responsibilities

Lead programming delivery for projects in CVRM
Implement statistical programming for clinical protocols
Ensure quality of project deliverables
Drive best practices in programming
Manage risks and project timelines

Project ManagementRisk Management

Posted about 1 month ago

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🔥 Principal Statistician– Late Phase- Cardiovascular, Renal, and Metabolism (CVRM)-(REMOTE)

Posted about 1 month ago

🔍 Pharmaceutical/healthcare

🔧 Requirements

MSc/PhD in Statistics or Mathematics (with a strong statistical focus) and significant experience in pharmaceutical/healthcare statistics or related fields.
Proven leadership capabilities to direct cross-functional teams and manage complex projects.
Extensive experience in data analysis and statistical interpretation in clinical trials, with a deep understanding of regulatory and technical requirements.
High proficiency in statistical programming (e.g., R and/or SAS), with a track record of applying these skills in drug development.
Strong collaboration skills, with the energy to work across global, cross-functional teams and external partners.
Experience in program and study design for clinical trials, particularly in early-stage clinical development.
Knowledge or experience in the Cardiovascular, Renal, and Metabolism (CVRM) therapeutic areas.
Experience with regulatory interactions, including presenting statistical findings and answering queries from regulatory bodies.

💡 Responsibilities

Lead statistical thinking within cross-functional teams, contributing significantly to early clinical development in the CVRM area.
Drive strategic planning and quantitative decision-making across drug development programs, ensuring robust statistical methodology is applied throughout.
Oversee delivery of statistical support on drug projects and studies, ensuring high quality, timeliness, and adherence to standards, collaborating with CROs and Programming teams as needed.
Lead methodological innovation by adapting or developing new statistical methodologies for early clinical trials, advancing the field through creative solutions.
Develop and implement new procedures and standards aimed at increasing efficiency, quality, and effectiveness across clinical development.
Acting as a subject matter expert in statistical methodologies, liaising with external collaborators and regulatory agencies.
Mentoring junior staff and fostering the development of talent by providing guidance, training, and support in statistical techniques.
Engaging with regulatory agencies, participating in meetings, and addressing statistical queries during regulatory submissions.

Posted about 1 month ago

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🔥 Senior Statistician Consultant- Late Phase Oncology (Remote in EU/UK)

Posted about 1 month ago

📍 EU, UK

🧭 Contract

🔍 Pharmaceutical, CRO

🔧 Requirements

MS or PhD in Statistics, Biostatistics or related field.
Strong oral and written communications skills, with ability to effectively communicate internally and with clients.
Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.

💡 Responsibilities

Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
Responsible for validity of analysis and explore alternative analysis strategies as needed.
Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians.
Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Mentoring

Posted about 1 month ago

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🔥 Senior STDM Statistical Programmer Consultant (Remote)

Posted about 1 month ago

📍 United States, Canada

🧭 Contract

🔍 Clinical Research

🔧 Requirements

Bachelor's or Master’s degree in computer science or related fields
5-6 years of clinical programming (CDISC) experience
Oncology TA experience
Knowledge of ICH and Good Clinical Practices
Understanding of clinical drug development process
Strong communication and coordination skills

💡 Responsibilities

Support programming deliveries of a clinical study or project
Implement statistical programming aspects of the protocol
Ensure high quality in deliverables
Write and implement specifications
Contribute to best practices for quality and efficiency
Plan and support team activities
Communicate and escalate risks

Posted about 1 month ago

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