clinical statistical programmer

ICON plc

<div>Statistical Programmer II<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Statistical Programmer II/Data Scientist to join our diverse and dynamic team. As a Statistical Programmer II at ICON, you will play a vital role in the development, validation, and execution of statistical programs to support clinical trial analysis and reporting. Your expertise will contribute to the accurate interpretation of clinical data, helping to ensure the successful delivery of research projects.</div><div></div><div>
What You Will Be Doing:</div><ul><li>
Developing and validating R-Shiny programs for statistical analysis and reporting of clinical trial data.</li><li>
Collaborating with biostatisticians and cross-functional teams to interpret study requirements and ensure the accurate implementation of statistical analyses.</li><li>
Preparing and reviewing statistical analysis plans (SAPs), programming specifications, and derived datasets to meet regulatory standards.</li><li>
Ensuring data integrity and compliance with industry regulations, including ICH/GCP guidelines, throughout the programming process.</li><li>
Mentoring junior programmers and assisting in training team members on programming techniques and best practices.</li></ul><div></div><div>
Your Profile:</div><ul><li>
5+years of experience in end-to-end programming in R, R Shiny and SAS preferred</li><li>
Bachelor&rsquo;s degree in statistics, mathematics, computer science, or a related field; advanced degree is a plus.</li><li>
Proven experience as a statistical programmer within the clinical research industry, with strong knowledge of statistical methodologies and programming.</li><li>
Proficiency in programming languages such as R/R-Shiny, SAS or Python, with experience in clinical data management systems.</li><li>
Strong analytical and problem-solving skills, with a keen attention to detail and the ability to work independently.</li><li>
Excellent communication skills, with the ability to convey complex statistical concepts to non-technical stakeholders and collaborate effectively with team members.</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Statistical Programmer II

Catalyst Clinical Research

<div><p><b>Catalyst Clinical Research</b> provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.</p><p><br>
Job Description</p><p></p><p><br>
4-Oct-24 Confidential</p><p></p><p><br>
JOB Title: Associate SAS Programmer</p><p></p><p><br>
Job summary:</p><p></p><p><br>
Develop SAS programs to produce high quality deliverables within set timelines in accordance with company and regulatory requirements.</p><p></p><p><br>
Key activities:</p><p></p><ul><li><br>
Use additional statistical packages like R, or other high-level programming languages as</li></ul><p></p><p><br>
appropriate.</p><p></p><ul><li><br>
Generate customized reports using PROCREPORT techniques</li></ul><p></p><ul><li><br>
Involve in Statistical programming and validation of Analysis Datasets and Tables,</li></ul><p></p><p><br>
Listings, Graphs (TLG'S)</p><p></p><ul><li><br>
Knowledge of CDISC services and hands on experience in developing SDTM datasets.</li></ul><p></p><ul><li><br>
Work closely with team, Statistician and prepare adhoc reports for analysis.</li></ul><p></p><ul><li><br>
Basic knowledge on SAS macros and ProcSQL.</li></ul><p></p><ul><li><br>
Understand Study specific documents like Protocol, SAP and give presentations.</li></ul><p></p><ul><li><br>
Understand all SOP&rsquo;s as part of the organization and ensure to adhere to all the rules and</li></ul><p></p><p><br>
responsibilities.</p><p></p><ul><li><br>
Develop numerous SAS programs with the help of SAS Statistical Procedures such as</li></ul><p></p><p><br>
ProcMeans, ProcTabulate, ProcFreq, Proc Summary.</p><p></p><p><br>
Qualifications:</p><p></p><ul><li><br>
MSC in Statistics and Effective Communication Skills.</li></ul><p></p><ul><li><br>
0 - 1year of experience, or an equivalent combination of education or experience</li></ul><p></p><ul><li><br>
Good understanding of Clinical Trials and the various terminologies</li></ul></div><p></p>

Associate Statistical Programmer

Tata Consultancy Services (TCS)

<div></div><div><div><div><div><p>Skill - <b>Statistical Programmer</b></p>
<p>
Job Location &ndash; <b>Mumbai, Pune, Bangalore, Noida</b></p>
<p>
Experience Range &ndash; <b>3 to 12 Years</b></p>
<p></p>
<p>Educational Qualification(s) Required &ndash; Graduate/Postgraduate (<b>Any life-science/ Engineering</b>)</p>
<div><b>
Required Skillsets:</b></div>
<div>
<ul><li>Proficiency in SAS / R programming languages to Program and validate <b>ADaM , TFL</b> and statistical analyses</li></ul>
<ul><li>Proficiency in using statistical software and programming tools</li></ul>
<ul><li>Familiarity with clinica l study protocols, statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and statistical programming documentation.</li></ul>
<ul><li>Knowledge of CDISC standards and therapeutic area (Oncology, Immunology , Neuroscience Etc.)</li></ul>
<ul><li>Experience in generating TLFs, programming macros, and data manipulation using SAS.</li></ul>
<ul><li>Good to have experience in other statistical programming languages (R).</li></ul>
<ul><li>Ability to interact professionally with statisticians, study teams, and external partners</li></ul></div><br>
<div></div>
<div><b>
Key Responsibilities:</b></div>
<div>
<ul><li>Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP). Implement Statistical Analysis Plans (SAP) and Statistical programming plan (SPP) to create ADaM data specifications.</li></ul>
<ul><li>requirements.</li></ul>
<ul><li>Develop and maintain programming documentation, such as annotated program code, programming specifications, and validation plans.</li></ul>
<ul><li>Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards.</li></ul>
<ul><li>Assist in the development and implementation of standard programming macros, utilities, and tools to improve efficiency and consistency in programming tasks</li></ul>
</div></div></div></div><div><div><div><b>Location</b></div>
<div>Mumbai</div>
</div><div><div><b>Job Function</b></div>
<div>BUSINESS PROCESS SERVICES</div>
</div><div><div><b>Role</b></div>
<div>Executive</div>
</div><div><div><b>Job Id</b></div>
<div>380461</div>
</div><div><div><b>Desired Skills</b></div>
<div>Life Sciences Domain</div>
</div></div><p>Desired Candidate Profile
</p><div><div><b>Qualifications</b> : BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), BACHELOR OF SCIENCE ( B.Sc Qualification ), BACHELOR OF SCIENCE (B.Sc), M.SC.</div></div></div><div></div>

Statistical Programmer

Capgemini Engineering

<div></div><div><div><div><div><p>Choosing <b>Capgemini </b>means choosing a place where you&rsquo;ll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what&rsquo;s possible. Join us in helping leading healthcare and life sciences organizations unlock the value of data and drive evidence-based, impactful research.
</p><p></p><h2 class="jobSectionHeader"><b>Your Role
</b></h2><p>As a Statistical Programmer II at Capgemini, you will be responsible for programming and validating clinical trial data displays, datasets, and documentation in alignment with regulatory standards. You&rsquo;ll collaborate with cross-functional teams and contribute to the delivery of high-quality statistical outputs for clinical research.
</p><h3 class="jobSectionHeader"><b>In this role, you will:
</b></h3><ul><li>Program tables, listings, and graphs for clinical study reports (CSRs).
</li><li>Develop customized data displays per statistical analysis plans (SAPs).
</li><li>Write code using Base SAS, SAS procedures, and standardized macros.
</li><li>Analyze protocols, SAPs, and shell templates to understand data structure.
</li><li>Perform data checks to ensure accuracy and integrity of displays.
</li><li>Create SAS datasets from clinical databases, including status and efficacy datasets.
</li><li>Prepare documentation for programs, datasets, and derived variables.
</li><li>Create project-specific macros and formats.
</li><li>Load and prepare client data for external transfers and imports.
</li></ul><h3 class="jobSectionHeader"><b>Additional Responsibilities for SP II:
</b></h3><ul><li>Assist in tracking project timelines and deliverables.
</li><li>Lead and mentor junior programmers in daily activities.
</li><li>Communicate with clients regarding risks, issues, and potential delays.
</li></ul><p></p><h2 class="jobSectionHeader"><b>Your Profile
</b></h2><ul><li>Bachelor&rsquo;s degree required; Master&rsquo;s degree in Biostatistics, Computer Science, Mathematics, or related field preferred.
</li><li>Strong SAS programming skills and understanding of clinical trial and drug development processes.
</li><li>At least 7 years of clinical or SAS programming experience (for SP II).
</li><li>Ability to manage multiple tasks and deliver high-quality outputs on time.
</li><li>Strong communication skills in English (verbal and written).
</li><li>Ability to work independently and collaboratively in dynamic environments.
</li><li>Understanding of data standardization and statistical reporting in clinical trials.
</li></ul><p></p><h2 class="jobSectionHeader"><b>What You&rsquo;ll Love About Working Here
</b></h2><p>We value flexibility and support our employees with remote work options and adaptable schedules to maintain a healthy work-life balance. Our inclusive culture brings together diverse professionals committed to growth, innovation, and excellence. You&rsquo;ll have access to continuous learning opportunities and certifications in emerging technologies and methodologies.
</p><p></p><h2 class="jobSectionHeader"><b>About Capgemini
</b></h2><p>Capgemini is a global business and technology transformation partner, helping organizations accelerate their dual transformation to address the evolving needs of customers and citizens. With a strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs&mdash;from strategy and design to operations.
</p><p>To achieve this, Capgemini draws on the capabilities of its 360,000 team members in more than 50 countries, all driven by the purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization with market-leading capabilities in digital, cloud, and data
</p>Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.</div></div></div></div>

Statistical Programming II

<div>Manager, Statistical Programming - India<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
At ICON, it&rsquo;s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients&rsquo; lives.<br>
<br>
Our &lsquo;Own It&rsquo; culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability &amp; Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.<br>
<br>
That&rsquo;s our vision. We&rsquo;re driven by it. And we need talented people who share it.<br>
If you&rsquo;re as driven as we are, join us. You&rsquo;ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you&rsquo;ll be helping shape an industry.<br>
<br>
Responsible and accountable for providing line management leadership to Statistical programming teams working across (ADaM, TLF, SDTM) within ICON Strategic Solutions.<br>
<ul><li>Ensure team deliverables are met to the expected quality within agreed timelines.</li><li>Mentor / develop teams under the guidance of Manager / Sr. Manager or designee.</li><li>Support Operations activities covering recruitment planning, interviewing, employee onboarding &amp; invoice management under minimal supervision.</li></ul>
Benefits of Working in ICON:<br>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a culture that rewards high performance and nurtures talent.<br>
<br>
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals &ndash; both ours and yours.<br>
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans &ndash; and related benefits such as life assurance &ndash; so you can save and plan with confidence for the years ahead.<br>
But beyond the competitive salaries and comprehensive benefits, you&rsquo;ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.<br>
<br>
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.<br>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.</div><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Manager, Statistical Programming

IQVIA

<div><div>Bachelor's degree from reputable university preferably in
<br>
science/ mathematics related fields
<br>
<ul><li>Preferred SAS&reg; certification
</li></ul>Technical Skills
<br>
Requirements
<br>
<ul><li>Must have expertise of SAS&reg; Base, and good knowledge of
</li></ul>SAS&reg; graph and SAS&reg; Macros.
<br>
<ul><li>Capable of implementing more advanced statistical
</li></ul>procedures as per specifications provided by biostatistician.
<br>
<ul><li>Must have excellent knowledge of CDISC standards (SDTM
</li></ul>and ADaM)
<br>
<ul><li>Thorough understanding of relational database components
</li></ul>and theory.
<br>
<ul><li>Excellent application development skills.
</li><li>Strong understanding of clinical trial data and extremely
</li></ul>hands on in data manipulations, analysis and reporting of
<br>
analysis results.
<br>
<ul><li>Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and
</li></ul>clinical research processes.
<br>
Experience requirements
<br>
Minimum of 8+ years of experience in Statistical Programming in
<br>
pharmaceutical or medical devices industry
<br>
Desirable requirements
<br>
<ul><li>Good verbal and written communication skills.
</li><li>Ability to work on multiple projects, plan, organize and
</li></ul>prioritize activities.
<br>
Responsibilities
<br>
At a minimum, following activities are required to be performed;
<br>
<ul><li>Perform all responsibilities associated with the Senior
</li></ul>Programmer role.
<br>
<ul><li>Assist all the Sr. Programmers and Programmers in their
</li></ul>day to day activities.
<br>
<ul><li>Act as escalation point for Sr. Programmer and
</li></ul>Programmer.
<br>
<ul><li>Regularly communicates with the sponsor on the progress
</li></ul>of programming aspects of the project and proactively
<br>
anticipates issues and works with the sponsor on resolution
<br>
of the problems
<br>
<ul><li>Provide input and/or write the programming specifications
</li><li>Serve as subject matter expert on all aspects of SAS
</li></ul>programming
<br>
<ul><li>Understand pharmaceutical industry standards and trends
</li></ul>and proactively plan, develop, and implement
<br>
<ul><li>Develop consistent practices of clinical and statistical
</li></ul>review of output and mentor programming staff
<br>
<ul><li>Check for consistency across therapeutic areas
</li><li>Identify, plan, and oversee the implementation and success
</li></ul>measures of all process improvement initiatives
<br>
<ul><li>Maintain expertise in the use of the SAS&reg; Macros and
</li></ul>determine macro development priorities
<br>
<ul><li>Other responsibilities as defined on ad-hoc basis by senior
</li></ul>management.
<br>
Relationship &amp; Interactions
<br>
<ul><li>Clinical data manager
</li><li>Biostatisticians
</li><li>Medical Coders
</li></ul></div><p></p><p>IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com</p></div>

Principal Statistical programmer

Exelo Technologies Inc

<p>We are seeking a highly skilled Senior Statistical Programmer to join our growing Biometrics team. The ideal candidate will be responsible for providing advanced programming support for the analysis and reporting of clinical trial data in compliance with regulatory requirements. This role will involve working closely with Biostatisticians, Data Managers, and Clinical Teams to deliver high-quality datasets, tables, listings, and figures (TLFs).</p><p><b>Key Responsibilities</b></p><ul><li>Develop, validate, and maintain SAS programs to generate analysis datasets (ADaM, SDTM) and TLFs for clinical trial submissions.</li><li>Ensure programming deliverables are accurate, efficient, and compliant with CDISC standards and regulatory guidelines.</li><li>Collaborate with Biostatistics and Data Management teams to understand study requirements and timelines.</li><li>Participate in the development of programming standards, macros, and process improvements.</li><li>Provide mentorship and guidance to junior programmers and review their work for quality and accuracy.</li><li>Support regulatory submissions (FDA, EMA, PMDA) by preparing submission-ready datasets and documentation.</li><li>Troubleshoot and resolve complex programming issues independently.</li></ul><p><b>Qualifications</b></p><ul><li>Bachelor&rsquo;s or Master&rsquo;s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.</li><li>5+ years of experience as a Statistical Programmer in the pharmaceutical, biotechnology, or CRO industry.</li><li>Strong proficiency in SAS programming; knowledge of R or other statistical software is a plus.</li><li>In-depth knowledge of CDISC SDTM and ADaM standards.</li><li>Experience supporting Phase I&ndash;IV clinical trials and regulatory submissions.</li><li>Excellent problem-solving, communication, and organizational skills.</li><li>Ability to work both independently and in a team-oriented environment.</li></ul><p><b>Preferred Qualifications</b></p><ul><li>Experience with eCTD submissions and regulatory agency interactions.</li><li>Familiarity with oncology, rare disease, or other therapeutic areas.</li><li>Knowledge of data visualization tools (e.g., R Shiny, Spotfire).</li></ul><p>Job Types: Full-time, Contract</p><p>Pay: $60,000.00 - $80,000.00 per year</p><p>Work Location: Remote</p>

Senior SAS Programmer

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