Open Positions

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)

Description

• Job Responsibilities:
  • Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
  • Develop SDTM specifications and generate SDTM datasets using SAS.
  • Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
  • Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
  • Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
  • Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.
  • Analyse information and develop innovative solutions to programming and data analysis challenges.
  • Actively communicate with statisticians for statistical input and analysis interpretation.
  • Follow and reinforce regulatory agency requirements during daily job.
  • Serve as a programming team lead and contribute to department initiative.
  • Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
  • Review draft and final production deliverables for project to ensure quality and consistency.

Requirements

• Qualification: Master’s / bachelor’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.
• Should have experience in end-to-end statistical programming (SDTM, ADaM and TLFs).

Years of Experience

• Should have 5-8 years of experience in end-to-end Statistical Programming in Clinical domain.

Skills

• • Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
  • Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members
  • Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
  • In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Good understanding of clinical drug development process.
  • Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
  • In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Good understanding of clinical drug development process.
  • Detail-oriented and ability to learn and adapt to changes.
  • Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.

Description

The Medical Safety Physician will take on roles involving the provision of medical and scientific judgment in the evaluation of data pertaining to the efficacy and safety of the company products including, but not limited to, the following:

• Prepare safety reports/documents, such as PBRER-PSURs, Benefit-Risk evaluations, and Risk Management Plans. Ensure the accuracy of the information presented.
• Review medical safety signals and ensure proper disposition and documentation. Review data from the company post-marketing database and related pharmacovigilance sources, as needed.
• Provide support in the preparation and conduct of cross-functional meetings which involve the medical safety organization (e.g., Safety Management Team meetings). Perform tasks hands-on as an individual contributor
• Provide leadership, mentoring, and guidance to other MSP/MSS including oversight of day-to-day activities and safety report content development
• Thoroughly understand and communicate stakeholder requirements to appropriate team members, and manage all requirements accordingly to realize each for the stakeholder
• Establish clear ownership for project tasks, ensure that team members have the tool needed, and provide timely feedback
• Coordinate and facilitate delivery of project objectives
• Assess project issues and identify solutions to meet productivity, quality, and customer goals
• Track progress, review project tasks, and prepare compliance metrics to make certain deadlines are met appropriately
• Maintain timelines and target dates
• To deliver any other task and/or responsibilities that may be assigned from time to time.

Requirements

• Ideal candidate must be a board-certified medical physician

Years of Experience

• 2 years of clinical experience in pharmaceutical medicine is required

Skills

• Technical skills: ability to analyze, interpret and present complex in a concise and understandable scientific manner, both orally and in written format, is essential
• Attention to detail; diligence in record-keeping and records organization; ability to manage a high workload and critical issues; computer-literate and proficient in MS Office applications
• Interpersonal skills: team player; display initiative; strong communication and presentation skills
• Internal and external networking skills: strong collaborative and interpersonal skills; results-oriented and able to independently create and deliver; ability to thrive in a global; cross-functional environment

Description

The Medical Writer plans and executes general medical writing activities and systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER) for assigned therapeutic area and projects.

Requirements

• Participates in the planning and execution of general medical writing activities and systematic literature reviews for assigned therapeutic area
• Prepares, writes, and edits creditable systematic literature reviews through the creation of protocols and reports in order to synthesize and analyze the clinical data from medical and scientific publications reporting on a range of medical devices
• Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes
• Performs data extraction of included studies into a data collection tool (e.g. Microsoft Excel, Distiller)
• Utilizes software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, QUOSA, SAS)
• Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports
• Organizes clinical data from literature into references, graphics, tables, and data listings
• Critically synthesizes clinical data being considered for presentation in the final report
• Performs scientific writing of the synthesized literature using templates
• Interprets and summarizes complex results from the medical and scientific literature and present them in clear, concise, and scientifically accurate manner to various end users requiring the ability understand and interpret statistical results of clinical studies
• Presents the results of systematic literature reviews at internal meetings