Open Positions

Description

• Responsibilities:
  • Maintains administrative staff by recruiting, selecting, orienting, and training employees; maintaining a safe and secure work environment; developing personal growth opportunities.
  • Accomplishes staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counselling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures.
  • Provides supplies by identifying needs for reception, switchboard, mailroom, and kitchen, establishing policies, procedures, and work schedules.
  • Provides communication systems by identifying needs; evaluating options; maintaining equipment; approving invoices.
  • Purchases printed materials and forms by obtaining requirements; negotiating price, quality, and delivery; approving invoices.
  • Completes special projects by organizing and coordinating information and requirements; planning, arranging, and meeting schedules; monitoring results.
  • Provides historical reference by developing and utilizing filing and retrieval systems.
  • Improves program and service quality by devising new applications; updating procedures; evaluating system results with users.
  • Achieves financial objectives by anticipating requirements; submitting information for budget preparation; scheduling expenditures; monitoring costs; analysing variances.
  • Maintains continuity among corporate, division, and local work teams by documenting and communicating actions, irregularities, and continuing needs.
  • Maintains professional and technical knowledge by attending educational workshops; benchmarking professional standards; reviewing professional publications; establishing personal networks.
  • Contributes to team effort by accomplishing related results as needed.

Requirements

• Any graduates or postgraduates.

Years of Experience

• Should have 5-7 years of experience in Administration & Facilities.

Skills

•   Facilities Management
  • Managing the Security & Housekeeping Staff
  • Stationary Procurement & maintenance
  • Asset Management
  • Event Management
  • Effective management and maintenance of office utilities.
  • Support employees & address their complaints & grievances regarding facilities.
  • Managing Cafeteria.
  • Vendor Management.
  • MIS Reporting related to Administrations & Facilities.

Description

Primary Responsibilities:

• The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, and safety update reports, etc.
  The Medical Writer may provide writing support for more complex clinical documentation, with appropriate departmental supervision. The Medical Writer may serve as primary technical contact with client under appropriate departmental supervision.

• Key responsibilities and skills may include:
  • Serve as the primary client contact under departmental supervision.
  • Serve as the Medical Writing representative on assigned project teams, providing support to Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables.
  • Providing support to Business Development Department for project bidding, document review and forecasting timeline.
  • Write clinical documents associated with submissions to regulatory authorities.
  • Serve as QCer to review peer`s clinical documents.
  • Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
  • Ensure document content and style adheres to appropriate regulatory guidelines and complies with departmental and corporate or client SOPs and style guidelines.
  • Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
  • Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
  • Attend internal technical team and client team meetings as required.
  • Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department.
  • Participate in departmental or interdepartmental process improvement and training initiatives.
  • Other assignment duties as assigned by department management.

Requirements

• Qualification: Bachelor’s degree or above in Life Sciences/Health Related Sciences or equivalent.

Years of Experience

• Should have 1-3 years of experience medical writing of regulatory documents such as CSR, protocol or similar in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications.

Skills

• • Experience in the pharmaceutical industry or medical writing.
• • Good clinical/scientific writing skills.
  • Excellent interpersonal, verbal and written communication skills.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
  • Good word processing skills/ familiarity with Word for Windows.
  • Experience with eCTD preferred.

Description

• The Safety Scientist should be willing to work in multiple projects; able to support case processing project, writing projects as an author or literature review project and support SSD as per the project requirements.

Roles & Responsibilities:

• The Product Safety Surveillance Scientist (PSS) has a primary responsibility and accountability for creating post‐marketing safety datasets, performing epidemiological analyses, and contributing to the writing of safety surveillance reports for a wide range of consumer and personal products.
  The PSS will work in close collaboration with surveillance physicians who will provide the complementary clinical review and medical assessment of these reports; with safety informatics and analytics leadership to test and implement enhanced surveillance systems capabilities; and with project management to ensure the compliance, timeliness and quality of deliverables.
  Under guidance of MSO, review disproportionalities generated by the Client Surveillance systems and signals originating from other sources.
  Triage and validate safety signals within agreed timelines and ensure proper disposition.
  Support MSO in evaluation of validated safety signals.
  Assess relevant cases and as applicable, review data from Client.
  Asses relevant cases and as applicable, review data from the Client post marketing database and related Pharmacovigilance sources such as but not limited to scientific literature and Health Authority databases.
  Provide the summary review to the MSO and surveillance physicians for their input.
  Track signal disposition in relevant tracking tool
  Communicate arising issues to the MSOs and surveillance physicians.
  Ensures filing of the developed documentation

Requirements

• Qualification: MBBS / MD with experience as Medical Reviewer

Years of Experience

• Should have 2 to 3 years on experience in Signal management activities.

Skills

• Experience in case processing and few months of SSD experience.
  Excellent written and verbal communication skills in English

Description

• Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Primary Responsibilities:

• Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
  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 regard to statistical methodology and provide appropriate training to less experienced statisticians.

Requirements

• Qualification – MSc or PhD in Statistics, Biostatistics or related field.

Years of Experience

• Should have 5 to 10 years of experience as Biostatistician.

Skills

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

Description

Position: Principal Statistical Programmer(Clinical Trials)

Employment type: FTE or contract

(REMOTE in EU/UK)

About ClinChoice

ClinChoice is a Global CRO dedicated to offering high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across the US, Canada, China, Europe, India, Japan, and the Philippines. It has over 3,000 employees globally, a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America, and Europe.

Summary

The Principal Programmer is accountable for the quality, timely, and efficient delivery of the project

programming work and good information management. This position requires profound programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers. It is a leadership role that can have a project or technical focus It will provide subject matter expertise within the Programming discipline. As an expert within their own field acts as a specialist within cross-functional teams to deliver continuous improvement

NOTE-If now is not the right time we would still be very interested in discussing our FSP contract brand for future opportunities. We are a Biometrics CRO that contracts directly with professionals. Feel free to contact us at clinchoice-career@clinchoice.com.

Responsibilities

• Leads and directs the full scope of project delivery and/or leads a technical project within the

TA/Drug Project/study/function

• Leads Implementation of statistical programming aspects of the protocol or clinical development

program

• Responsible for the high quality of all project deliverables, holding partners, and providers

accountable for the quality of their deliverable and/or technical subject matter expert for aspect(s)

of the TA, Project, or function

• Leads or contribute to cross-functional administrative or process improvement initiative(s)

• Drives the development of best practices to improve quality, efficiency, and/or effectiveness

within the function

• Drives standards development and implementation

• Manages and escalate risk in complicated or novel situations within their study and/or projects

• Provides Programming expertise to the team

• Provides tactical input and/or drives ideas and improvements

• Contributes to the function by supporting recruiting and/or providing training and mentorship

• Identifies opportunities to improve methodology and provides practical solutions for problems

• Influences stakeholders by providing subject matter expertise on programming-related items

• Ensures compliance with standards and automation usage

• Employs all project management practices in managing drug or technical projects

• Provides input to capacity management for all projects in scope

• Maintains expertise in the latest industry and regulatory requirements to stay current

Qualifications and Experience

• Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life

Science or equivalent with 8+ years of related experience in programming. 

• Proven programming expertise

• Thorough knowledge of the clinical development process

• Thorough knowledge of industry standards and ability to implement them

• Ability to apply programming expertise to problem-solving and troubleshooting for teams

• Current knowledge of technical and regulatory requirements relevant to the role

• Ability to proactively manage concurrent activities within a project

• Proficient ability to influence relevant stakeholders on programming-related items

• Ability to manage risk in complicated or novel situations

· • Project Mindset

ClinChoice is an Equal Opportunity Employer / Committed to Diversity

Description

Title: Senior Biostatistician-Late Phase
Employment type: FTE OR Contract

100% Remote anywhere in EU/UK

About ClinChoice

ClinChoice is a global CRO dedicated to offering high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across US, Canada, China, Europe, India, Japan, and the Philippines. It has over 3,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America, and Europe.

NOTE-If now is not the right time we would still be very interested in discussing our FSP contract brand for future opportunities. We are a Biometrics CRO that contracts directly with professionals. Feel free to contact us at clinchoice-career@clinchoice.com

Summary
Assignments for Senior Biostatistician Consultant are to provide Biostatistical support and work on key client deliverables involving designing and analyzing clinical trials.

Key responsibilities include, but are not limited to:

• 3+ years’ experience preferred leading late-phase studies.
• Modeling experiences such as Mixed Models, Cox Models, Kaplan, Mier Estimates, and Poison Modeling would be a plus.
• Protocol development including study design, sample size estimation, randomization, and statistical analysis plan for assigned studies.
• Statistical oversight of studies and assure adequate quality and consistency with project requirements.
• Responsible for the accuracy and completeness of database quality checks and 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 alternative analysis strategies when unforeseen circumstances arise.
• Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
• Responsible for the accuracy and consistency of statistical tables, figures, and data listings, the 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 flaws in the interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
• Effectively coordinate assignments and review deliverables so that projects are delivered on time with high quality.
• Other duties and responsibilities as required and depending on specifics of client projects

Requirements:

• MS or Ph.D. in Statistics, Biostatistics, or a related field. Ph.D. with 4+ years of related experience, or MS with 6+ years of experience.
• A high degree of technical competence and communication skill, both oral and written.
• Competent in experimental design, descriptive and inferential statistics.
• Pharmaceutical, CRO, or related industry experience with clinical trials.

Clinchoice is an Equal opportunity Employer/committed to diversity

Description

Title: Principal Biostatistician
Employment Type: FTE/Contract
100% Remote work – anywhere in EU/UK

About ClinChoice

ClinChoice is a global CRO dedicated to offering high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across the US, Canada, China, Europe, India, Japan, and the Philippines. It has over 3,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America, and Europe.

NOTE-If now is not the right time we would still be very interested in discussing our FSP contract brand for future opportunities. We are a Biometrics CRO that contracts directly with professionals. Feel free to contact us at clinchoice-career@clinchoice.com

Summary

Assignments for Principal Biostatisticians are to provide Biostatistical support and work on key client deliverables involving designing and analyzing clinical trials.

Key responsibilities include, but are not limited to:

• 3+ years’ experience preferred leading late-phase studies Modeling experiences such as Mixed Models, Cox Models, Kaplan, MierEstimates, and Poison Modeling would be a plus
• 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 the accuracy and consistency of statistical tables, figures, and data listings, the 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 assures 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.

Requirements:

• MS or Ph.D. in Statistics, Biostatistics, or related field. Ph.D. with 3-5 years of experience or MS with 6-8 years of experience.
• Strong oral and written communications 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 FDA.

Clinchoice is an Equal opportunity Employer/committed to diversity

Description

Associate Director, Biostatistics_Compound development
Contract role with FSP
Remote- anywhere in EU/UK

About ClinChoice

ClinChoice is a global CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients. Our services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major offices across US, China, Europe, India, Japan, and the Philippines with over 2,400 employees globally.

NOTE-If now is not the right time we would still be very interested in discussing our FSP contract brand for future opportunities. We are a Biometrics CRO that contracts directly with professionals. Feel free to contact us at clinchoice-career@clinchoice.com.

Summary

The Associate Director, Biostatistics provides expert consultation and statistical advice, as well as, strategic leadership from plan to execution during all Phases of drug development. Provide direction to statisticians on statistical and programming principles and methodology. Perform supervisory and management functions relating to the administrative and scientific activities of statisticians. Develop and direct appropriate and innovative study design, analysis, and reporting of clinical study results. As a formal member of a cross-functional clinical drug development team, plan and implement clinical drug development programs. Major responsibilities and accountabilities include, but are not limited to:

• Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
• Responsible for an area of significant corporate impact and line management for a group of highly trained professionals.
• Provide strategic and statistical leadership; lead the statistical group to complete projects in a timely and quality manner.
• Represent statistical group and give expert consultation and advice in project planning and corporate level meetings; identify mission-critical needs of the departments.
• Supervise the activities of statisticians, be proactive in resolving issues and establishing team performance standards to ensure that the team functions with the highest efficiency. Establish effective relationships with clients.
• Establish and ensure the use of standards for the analysis and reporting of clinical study data.
• Contribute to the implementation and execution of the drug development plan, and assist in the determination of strategic objectives for regulatory filing.
• Independently develop statistical methodology appropriate for the analysis of clinical studies utilizing knowledge of regulatory guidelines and statistical methodology.
• Participate in conducting statistical research and developing design, analysis, and innovative statistical methodologies to improve the drug development process.

Qualifications

• MS or PhD in Statistics, Biostatistics, or a related field. Ph.D. with 6+ years related experience or MS with 8+ years of experience.
• Strong oral and written communication skills, with the ability to communicate effectively throughout all levels of the organization.
• Demonstrated capability to set clear priorities and effectively manage multiple projects.
• Demonstrated understanding and insight in statistics, drug development process, and relevant FDA regulations.
• Demonstrated ability to identify areas of statistical research in improving the design, analysis and reporting of clinical study.
• Demonstrated pharmaceutical or related industry experience with clinical trials and interaction with Regulatory Agencies, especially FDA.

ClinChoice is an Equal Opportunity Employer / Committed to Diversity

Description

Title: Senior Statistical Programmer/Consultant

Employment type: FTE or Contract

Contract with FSP client

100% Remote

About ClinChoice

ClinChoice is a global CRO dedicated to offering high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across US, Canada, China, Europe, India, Japan, and the Philippines. It has over 3,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America, and Europe.

NOTE-If now is not the right time we would still be very interested in discussing our FSP contract brand for future opportunities. We are a Biometrics CRO that contracts directly with professionals. Feel free to contact us at clinchoice-career@clinchoice.com.

Summary

The Senior Statistical Programmer/Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the Programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks.

Job Description:

• · 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.

Qualifications and Experience

• · BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related field plus 6-7 years of SAS programming experience in a clinical trial environment
• · MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related field plus 5 or more years of SAS programming experience in a clinical trial environment
• · Excellent programming skills including macro language
• · Ability to proactively manage concurrent activities within a study or part of the project
• Proficient knowledge of the clinical development process.

Clinchoice is an Equal opportunity Employer/committed to diversity

Description

• This role reports to the Manager, Statistical Programming, and above
• Produces complex statistical analysis using SAS/R according to relevant standard operating procedures.
• Ensuring compliance to SOPs and internal process for the project managed
• Programming analysis dataset without specifications and review of SAS programs in the designated clinical trail
• Develop SDTM/ADaM specifications as per the company or client standards
• Ensure the project team delivers the projects within agreed timelines and quality standards. Ability to lead multiple studies (e.g., CSR, DMC, PSUR/DSUR, etc.)
• Developing SAS Programs for the complex statistical analysis of study data, including analysis of datasets, tables, listings, and figures
• Programming according to CDISC SDTM and ADaM datasets
• Review Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines
• Create an electronic submission package to FDA, e.g., Patient Profile or Subject Narratives, ISO Listings, define.xml, or define.pdf following FDA guidelines.
• Preparing and performing internal training on statistical programming processes and techniques. Support the less experienced team for technical issues
• Make certain that the study team ensures project documents and specifications are consistent and comply with company/client standards by providing the inputs into study SAP, Protocol, CRF, and outputs
• Provide guidance, mentoring, and training for junior team members and help solve issues from cross-functional teams
• Represent ClinChoice/Department during internal and external audits
• Communicating effectively with the internal project team and global team. Collaborate closely with the study/working group.
• Anticipate/identify the risk or issues within the project and proactively communicate to the trial lead or manager
• Actively present lesson learning/ best practices/ best approaches in knowledge-sharing meetings, ask questions, and share feedback continuously to improve the process or standards of the programming.

• Proactively communicate and collaborate with the global team by understanding the time zone differences.
• Support the resourcing manager for effective resource allocation and team utilization within the study budget
• Drive innovative solutions or projects to improve the process or programming methodologies or patterns or solutions.
• Conducts other statistical programming activities as required
• Conduct other administrative and departmental activities as needed.

Requirements

• Bachelor’s degree or equivalent required, preferably in life science, statistics, computer science, or related subjects

Years of Experience

• At least 3 years of experience within the pharmaceutical industry with clinical programming and clinical development processes across therapeutic areas.

Skills

• Comprehensive knowledge and experience in study setups, different processes, tasks such as SDTM, SDRG, ADaM, ADRG, TFL, ISS/ISE, Define XML, ISO Listings, Macro Programming, etc. and analysis of the requirements for clinical programming projects.
• In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology, e.g., ICH-GxP, E3, E6, etc.
• Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.
• Excellent written and verbal communication skills, collaboration, and interpersonal skills.
• Strong experience in ADaM programming (Development and Validation)
• Strong experience in TLF programming (Development and Validation)
• Strong experience in SAS Programming
• Good Knowledge or Strong Experience in SAS Macro Programming.
• It is preferable to have R/Python experience (Not a mandatory requirement)