Clinical Outcomes Solutions

Clinical Research

• Providing statistical support to clinical studies, with a focus on Rare Disease;
• Participating in the development of study protocols, including participation in study design discussions and sample size calculations;
• Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
• Performing statistical analyses;
• Interpreting statistical results;
• Preparing clinical study reports, including integrated summaries for submissions;
• Leading study activities when called upon;
• Utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
• Serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.

Principal Biostatistician, FSP

Software Engineer

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
• Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
• Production and QC / validation programming
• Generating complex ad-hoc reports utilizing raw data
• Applying strong understanding/experience of Efficacy analysis
• Creating and reviewing submission documents and eCRTs
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• Performing lead duties when called upon
• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Being adaptable and flexible when priorities change
• Experience in RWE would be an added advantage.

Senior Statistical Programmer, FSP

• **As a Senior Biostatistician, your responsibilities will include: **
• - Providing statistical support to clinical studies
• - Participating in the development of study protocols, including participation in study design discussions and sample size calculations
• - Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications
• - Performing statistical analyses and interpreting statistical results
• - Preparing clinical study reports, including integrated summaries for submissions
• - Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.
• - Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• - Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• - Participate in the development of CRFs, edit check specifications, and data validation plans
• - Provide review and/or author data transfer specifications for external vendor data
• - Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• - Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Senior Biostatistician – FSP

Data Scientist

• Responsible for independently leading data management study activities, CRO oversight, and driving deliverable timelines.
• Strong knowledge of EDC builds utilizing RAVE.
• Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and client for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Contributes influential leadership in collaboration with other client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
• Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
• Provides input to functional governance with client strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
• Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
• Participates and represents function in formal inspections and audits as requested.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
• Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
• Acts as a process expert for operational and oversight models.
• Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
• May prepare metrics to support the function’s KPIs.
• Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of client.
• Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
• Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
• Performs other duties as assigned.

Senior Clinical Data Manager

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
• Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
• Production and QC / validation programming
• Generating complex ad-hoc reports utilizing raw data
• Applying strong understanding/experience of Efficacy analysis
• Creating and reviewing submission documents and eCRTs
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• Performing lead duties when called upon
• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Being adaptable and flexible when priorities change

Senior Statistical Programmer

• Lead Phase II-III clinical studies across the region, providing statistical and development support and influence for client's trials.
• Formulate integrated analytical approaches to mine data sources and employ statistical methods, machine learning and deep learning to discover insights and automate processes.
• Provide statistical input into study protocols, Case Report Forms, data management plans, and Data Monitoring Committees (DMCs).
• Write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Incorporate Estimand framework while authoring study documents.
• Create specifications and perform analyses such as time-to-event and longitudinal analysis.
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers; lead electronic submissions and participate in meetings with regulatory authorities.
• When in Lead Biostatistician role: manage biostatisticians and statistical programmers regarding strategy, deliverables and processes.
• Develop collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
• Generate and apply innovative statistical methodology appropriate to projects and contribute to company visibility.

Principal Biostatistician – Late Phase Development

• Working fully embedded within a pharmaceutical client as a Senior Statistical Programmer supporting Phase I-IV clinical trials
• Leverage advanced SAS programming skills and proficiency in CDISC SDTM & ADaM to generate and validate datasets, analysis files, and TLFs
• Perform data manipulation, analysis and reporting of clinical trial data (safety and efficacy, ISS/ISE)
• Production and QC/validation programming and generating complex ad-hoc reports
• Create and review submission documents and eCRTs and support submissions
• Communicate with internal cross-functional teams and client for project specifications, status, issues or inquiries
• Perform lead duties when called upon and collaborate within globally dispersed teams

• As Principal Biostatistician, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-III clinical studies, with a focus on Neurology therapeutic area. This position reports to the Director of Biostatistics in FSP Services business unit in Cytel.
• You will contribute by:
• providing statistical support to clinical studies, with a focus on Neurology;
• participating in the development of study protocols, including participation in study design discussions and sample size calculations;
• reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
• performing statistical analyses;
• interpreting statistical results;
• preparing clinical study reports, including integrated summaries for submissions;
• leading study activities when called upon;
• utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
• serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
• being adaptable and flexible when priorities change

Principal Biostatistician, Clinical Development

Backend Engineer

• Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
• We are seeking a highly experienced and strategic Principal Database Developer to lead the transformation of clinical data infrastructure. This role is pivotal in reengineering core database development workflows, designing scalable and compliant data systems, and ensuring seamless integration across clinical trial phases. You are passionate about innovation, thrive in collaborative environments, and consistently push the boundaries of what clinical data systems can achieve.
• Sponsor-dedicated:
• Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Database Developer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Principal Database Developer

Operations

• Strategic Operations Manager-Data Management
• Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
• Who Are You?
• We are seeking a proactive and detail-oriented Strategic Operations Manager to support a transformative Data Management initiative. This role is critical in driving project timelines, coordinating cross-functional efforts, and ensuring that milestones are met with precision and quality. You are organized, communicative, and passionate about clinical data. You thrive in fast-paced environments and are excited to contribute to a high-impact program that is reshaping the future of data management.
• Sponsor-dedicated:
• Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Strategic Operations Manager you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. You will be part of the team focused on this transformation initiative with support from both Cytel and our Client. This is an exciting time to be a part of this new program.