Health insurance

Job/Soft skill training

Cafeteria

Cytel Statistical Software & Services Reviews by Employees

JOB DESCRIPTION : 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 Statistical Programmer 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. Position Overview : This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials. Responsibilities : As a Principal Statistical Programmer, your responsibilities will include : - Generate SDTM, ADaM specifications, datasets, reviewers guide and define.xml files for multiple studies. - Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs. - Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs needs. - Participate in overseeing CROs statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines. - Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses. - 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. 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. Qualifications : Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have : - At a minimum bachelors degree in computer science, data science, mathematics, or statistics major preferred. - 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies. - Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment. - Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation. - Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities. - Must be able to work independently. - Outstanding communication skills (written and verbal) and strong leadership skills. Preferred Qualifications (nice To Have) : - Prior work experience with pharmacokinetic data and the neuroscience field, proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git).

Others

Cytel - Principal Statistical Programmer - R/Python (7-10 yrs)

Responsibilities : - Participate actively in requirements discussions and discuss technical aspects, thereby helping the team develop a good understanding of detailed functional and non-functional requirements. - Ensure on-time and high-quality delivery of software by working independently and productively, developing complex features, and debugging and fixing complex bugs. - Assist Tech Lead with analyzing defects and the impact of required code changes and discuss impact with testers. - Follow all applicable software engineering processes and complete necessary documentation. - Assist Tech Lead with planning and ensuring successful code integration across various layers of the application. - Assist Tech Lead with high level design and other technical documentation. - Perform code refactoring under guidance. - Actively participate in sprint planning, daily stand-ups, sprint demos, and retrospectives. - Develop a T-shaped technical skillset by undergoing appropriate trainings and courses and attending relevant industry events. - Follow all applicable company policies. - Adhere to Cytels values and acquire the competencies required to succeed in your job. Qualifications : Education : - Bachelors or Masters degree in Computer Science & Engineering (CSE) or equivalent STEM degree are preferred; however, experienced candidates from other disciplines with strong software development skills may also be considered. Experience And Skills : - At least 5 years of experience in developing desktop apps or web apps. - In case of web development, experience using technologies like React, Angular, or .NET Core with C# (any one of these) preferred. - In case of prior web development experience, strong knowledge of web development using HTML, CSS, JavaScript required. - For back-end developers, basic knowledge of databases (e.g., PostgreSQL) required. - Experience of code reviews, knowledge of strong coding practices, and experience of using Cytels standard development tools (Jira, Confluence, BitBucket / Git, Visual Studio / VS Code). - Experience working in Agile teams and knowledge?of frameworks like Scrum. - Quick learner with strong numerical & verbal aptitude, logical reasoning, and analytical ability. - Self-driven with the ability to think creatively and solve complex problems. - Strong verbal and written English communication skills. - Collaborative mindset and strong interpersonal skills.

Pune

Cytel - Software Engineer - C#/React.js (5-8 yrs)

Senior Programmer Join Cytels enthusiastic and collaborative Biometrics team by contributing to the overall success of one of our major pharma clients. Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward. We are experiencing exponential growth on a global scale and hiring Senior Statistical Programmers to join our FSP division. You will apply your know-how in CDISC standards (SDTM & ADaM) and advanced SAS programming skills, to support or lead one or more Phase I-IV clinical trials, across a variety of therapeutic areas. This role can be performed as fully remote. Our values : We believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. We prize innovation and seek intelligent solutions using leading-edge technology. How You Will Contribute : - Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming - Generating and validating analysis datasets/analysis files, and complex tables, listings, and figures ( TLFs) - Production and QC / validation programming - Generating complex ad-hoc reports utilizing raw data and analysis datasets - Applying strong understanding/experience of Safety and Efficacy analysis - Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries - Performing lead duties for assigned clinical study under principle programmers oversight - 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 - Being able to create specifications for derived/analysis datasets - Generating and validating Non-CDISC transformation datasets and analysis datasets - Proficient knowledge with SDTM/ADaM and TLFs. - General expertise with Figures - Individuals should be able to start programs from scratch and have the ability to handle complicated domains and outputs related to the protocol and SAP. - Creating and reviewing submission documents and eCRTs - They must demonstrate a good understanding of the endpoints and data collection, with the ability to read and write specifications related to the respective implementation guides. - R & complex macro writing are a plus What You Offer : - Bachelors or masters degree in one of the following fields Statistics, Computer Science, - At least 8 years of SAS programming working with clinical trial data with a bachelors degree or equivalent. - At least 6 years of related experience with a masters degree or above. - Familiarity with ICH E3 (Structure and Content of CSR) and E9 (Stat Principles). - Well conversant with regulatory requirements and drug development process. - Study lead experience, preferably juggling multiple projects simultaneously. - Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH - Strong CDISC (both SDTM and and ADaM) experience is required. - Solid ADaM and complex TFL skills. - Strong QC / validation skills. - Good ad-hoc reporting skills. - Experience in pooling/ ISS/SE studies is an asset. - Experience with cross-over studies is a plus. - Submissions experience utilizing define.xml, creation of annotated CRF, data reviewers guides and other submission documents. - Excellent analytical & troubleshooting skills. - Being flexible to adapt and use clients macro codes. - R programming knowledge for data manipulation and graphs is an asset. - Ability to provide quality output and deliverables, in adherence with challenging timelines. - Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. - Applied experience in one of the following therapeutic area is a plus: oncology, rare diseases, gastroenterology, respiratory, immunology, hepatitis and vaccines. - Experience in medical affairs is a plus

Anywhere in India/Multiple Locations

Cytel - Senior Statistical Programmer - SAS Programming (8-10 yrs)

Apply to 3 Cytel Statistical Software & Services jobs on Hirist.tech, India's No.1 IT job portal. Explore IT job in Cytel Statistical Software & Services Now! 

Jobs by location

Cytel Statistical Software & Services Jobs