ClinChoice

Related companies:

Jobs at this company:

Apply

🔥 Senior Statistician Consultant-R&I (Respiratory & Immunology)REMOTE@US

Posted 7 days ago

📍 US

🧭 Contract

🔍 Pharmaceutical, CRO

MS or PhD in Statistics, Biostatistics, or related field.
PhD with 2-4 years of experience or MS with 5-7 years of experience.
Strong SAS skills.
Experience with Respiratory & Immunology TA, particularly asthma studies.
Strong oral and written communication skills.
Understanding of statistics and the drug development process.

Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan.
Provide statistical oversight and quality assurance for studies.
Ensure data completeness, accuracy, and consistency.
Manage statistical analysis plans and ensure accuracy in reports.
Mentor peers on statistical methodologies.
Coordinate and review work of statisticians across projects.

Posted 7 days ago

Apply

🔥 Senior Biostatistician Consultant-ONCOLOGY(REMOTE IN EU/UK)

Posted 10 days ago

📍 EU/UK

🧭 Contract

🔍 Clinical research, pharmaceutical

MS or PhD in Statistics, Biostatistics or related field.
PhD with 3-5 years of experience or MS with 6-8 years of experience.
Strong experience with Oncology therapeutic area.
Strong oral and written communication skills.
Understanding of statistics, drug development, and relevant FDA regulations.
Experience in pharmaceutical, CRO, or related industry with clinical trials.

Responsible for protocol development including study design, sample size calculation, and statistical analysis plan.
Provide statistical oversight to studies for quality and consistency.
Ensure data for analyses are complete, accurate, and consistent.
Maintain accuracy and timeliness of statistical inputs into reports.
Explore alternative analysis strategies as needed.
Mentor peers and provide training to less experienced statisticians.
Coordinate and review the work of statisticians across projects.

MentoringTrainingData management

Posted 10 days ago

Apply

🔥 Lead/Principal Statistical Programmer Consultant(Hematology/Oncology-Clinical Trials) REMOTE@EU/UK

Posted 10 days ago

📍 European Union; United Kingdom

🧭 Contract

🔍 Clinical development

Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
Need to have Oncology TA experience.
Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
Good understanding of the clinical drug development process.
Strong communication skills and coordination skills.
Current knowledge of technical and regulatory requirements relevant for the role.
Ability to proactively manage concurrent activities within a project.
Proficient ability to influence relevant stakeholders on programming-related items.

Responsible for supporting the Programming deliveries of a clinical study or project.
Implements statistical programming aspects of the protocol and the clinical development program.
Ensures high quality is built into own deliverables and the quality delivered by other programmers.
Programs independently with high efficiency and quality.
Writes and/or implements specifications and oversees completeness of relevant documentation.
Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
Ensures compliance with standards and automation usage.
Plans and support team activities and tasks.
Communicates and escalates risks within the assigned studies and/or projects.
Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.

Data management

Posted 10 days ago

Apply

🔥 REMOTE Manager, Regulatory Affairs Strategy - Clinical Development

Posted 10 days ago

📍 United States

🧭 Permanent

🔍 Pharmaceutical, biotechnology, medical device, and consumer health

Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Biotechnology) or equivalent; advanced degree preferred.
Minimum of 8 years of regulatory experience in the pharmaceutical or biotechnology industry, with a focus on clinical development.
Extensive knowledge of global regulatory submission and approval processes.
Proven ability to manage regulatory submissions.
Strong communication and leadership skills.

Responsible for developing and implementing global regulatory submission strategies for global clinical trials.
Lead regulatory activities and address regulatory questions and concerns.
Participate in proposal preparation and bid defenses, collaborating with global teams.
Provide regulatory guidance for drug and medical device clinical trials.
Manage regulatory submission activities, including planning, authoring, and reviewing submissions.
Ensure regulatory contributions achieve strategy objectives, standards, and facilitate EU submission activities.

Strategic ManagementCross-functional collaboration

Posted 10 days ago

Apply

🔥 Senior Statistician Consultant-R&I(Respiratory & Immunology)REMOTE@EU/UK

Posted 10 days ago

📍 European Union

🧭 Contract

🔍 Pharmaceutical, biotechnology, clinical development

MS or PhD in Statistics, Biostatistics or related field.
PhD with 2-4 years of experience or MS with 5-7 years of experience.
Strong SAS skills.
Experience with Respiratory & Immunology TA, specifically Asthma Study.
Strong oral and written communication skills.
Demonstrated understanding of statistics and drug development processes.

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 adequacy in quality and consistency with project requirements.
Ensure the accuracy and completeness of data for statistical analyses.
Manage and mentor junior statisticians across projects, ensuring timely delivery and high quality.

Data Analysis

Posted 10 days ago

Apply

🔥 Lead/Principal Statistical Programmer Consultant(Hematology/Oncology-Clinical Trials) REMOTE

Posted 11 days ago

📍 United States

🧭 Contract

🔍 Clinical development, pharmaceutical, biotechnology, medical device, consumer health

Bachelor’s degree in computer science, statistics, or related scientific disciplines with 6 years of clinical programming (CDISC) experience; Master’s degree with 8 years of experience.
Oncology/Hematology TA experience is required.
Experience with ISS & ISE is required.
Working knowledge of ICH, Good Clinical Practices, clinical research, clinical trial process, and related regulatory requirements.
Good understanding of the clinical drug development process.
Strong communication and coordination skills.
Current knowledge of technical and regulatory requirements for the role.
Ability to manage concurrent activities proactively.

Lead and support all programming activities per project strategies.
Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs and from scratch for new outputs.
Customize outputs and graphics according to delivery specifications.
Support Programming deliveries of clinical studies.
Program independently with high efficiency and quality.
Contribute to best practices for quality and efficiency.
Ensure compliance with standards and usage of automation.
Plan and support team activities and tasks.
Communicate and escalate risks within assigned studies.

SAS EG

Posted 11 days ago

Apply

🔥 Senior Biostatistician Consultant-Oncology (Remote in US)

Posted about 1 month ago

📍 United States

🧭 Contract

🔍 Clinical research and development

MS or PhD in Statistics, Biostatistics or related field.
PhD with 3-5 years or MS with 6-8 years of experience.
Strong experience in Oncology therapeutic area.
Excellent oral and written communication skills.
Understanding of statistics, drug development processes, and FDA regulations.
Experience in pharmaceuticals, CRO, or related industry with clinical trials.

Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan.
Provide statistical oversight and ensure data quality and consistency.
Create statistical analysis plans and ensure timely reporting.
Validate analysis, explore alternative strategies, and correct flaws in interpretation.
Mentor peers in statistical methods and manage statistical activities across projects.

LeadershipData AnalysisCommunication SkillsAnalytical SkillsCollaborationProblem SolvingMentoringAttention to detailOrganizational skillsTime ManagementWritten communicationDocumentationCoaching

Posted about 1 month ago

Apply

🔥 Senior Data Manager_Remote @ US/CAN (Contract role)

Posted about 2 months ago

📍 US, CAN

🧭 Full-Time

🔍 Clinical research organization (CRO)

Minimum BA/BS in scientific or health-related field.
Minimum of 5 - 7 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO.
Oncology or auto-immune experience required.
Comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, etc.).
Proficient with Medidata RAVE and familiarity with Medidata Suite products preferred.
Excellent communication skills (verbal and writing).
Ability to multi-task and take on new responsibilities in a fast-paced, small company setting.
Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.).
Strong organizational skills and ability to prioritize tasks.
Proven ability to work independently and in a team setting.

Act as Lead Data Manager across one or more clinical studies and lead all aspects of data management activities.
Provide expertise and oversight of all clinical database activities from design/start-up to closeout.
Review protocols for appropriate data capture including electronic (eCRF) design.
Support CRF design, review, and validation of the clinical database.
Provide oversight of database set-up/migrations/upgrades including coordinating User Acceptance Testing.
Conduct oversight of data management vendors and ongoing review of quality and performance metrics.
Generate, resolve, and track data queries to ensure clinical data integrity.
Facilitate and participate in data cleaning activities.
Generate/review/approve various study documents related to data management.
Review CRF metrics reports against project data deliverables.
Maintain internal data management timelines and metrics, ensuring inspection readiness.
Identify potential data management issues/risks and communicate within the study team.
Participate in process improvement activities.

LeadershipProject ManagementData AnalysisCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaborationMicrosoft ExcelProblem SolvingMicrosoft OfficeAttention to detailOrganizational skillsTime ManagementWritten communicationMultitaskingDocumentationMicrosoft Office Suite

Posted about 2 months ago

Apply

🔥 Manager, Regulatory Affairs Strategy - Clinical Development

Posted 2 months ago

📍 UK

🧭 Permanent

🔍 Pharmaceutical, biotechnology, medical device, and consumer health

Bachelor's degree in a scientific discipline; advanced degree preferred.
Minimum of 8 years of regulatory experience in the pharmaceutical or biotechnology industry.
Extensive knowledge of global regulatory submission and approval processes.
Proven ability to manage regulatory submissions.
Strong communication and leadership skills.

Develop and implement global regulatory submission strategies for clinical trials.
Lead regulatory activities and address regulatory questions and concerns.
Participate in proposal preparation and bid defenses.
Collaborate with global teams to support regulatory submission management.
Provide guidance on regulatory requirements and represent regulatory in strategy discussions.
Manage interactions with regulatory authorities and provide strategic input into submissions.

Project Management

Posted 2 months ago

Apply

🔥 Client Success Manager

Posted 2 months ago

📍 United States

🧭 Full-Time

🔍 Life Sciences, Pharmaceutical, Medical Devices, Biotech

Bachelor’s degree in a technical or business field; advanced degree preferred (e.g., MBA, MS, PhD).
5+ years of applicable business, sales, or consulting experience.
2-3 years leading major programs for Global 1000 companies; consulting firm experience preferred.
Clinical, safety, or regulatory domain knowledge to understand client marketplace and business drivers.
Strong executive presentation and communication skills.

Cultivate and lead relationships with existing clients in pharmaceutical, medical devices, and biotech sectors.
Advise clients on strategic issues for long-term partnership.
Support sales activities and business expansion by engaging with clients.
Lead the coordination of RFP responses and client presentations.

LeadershipProject ManagementBusiness DevelopmentData AnalysisProduct ManagementProject CoordinationCross-functional Team LeadershipStrategyGoCommunication SkillsAnalytical SkillsCollaborationProblem SolvingNegotiationAttention to detailOrganizational skillsPresentation skillsTime ManagementWritten communication

Posted 2 months ago

Apply

Shown 10 out of 11

ClinChoice

Related companies:

Jobs at this company:

🔧 Requirements

💡 Responsibilities

🔧 Requirements

💡 Responsibilities

🔧 Requirements

💡 Responsibilities

🔧 Requirements

💡 Responsibilities

🔧 Requirements

💡 Responsibilities

🔧 Requirements

💡 Responsibilities

🔧 Requirements

💡 Responsibilities

🔧 Requirements

💡 Responsibilities

🔧 Requirements

💡 Responsibilities

🔧 Requirements

💡 Responsibilities