Senior/Principal Statistical Programmer SAS + R (Remote)
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 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
- Generate SDTM, ADaM specifications, datasets, reviewer's 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 CRO's 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.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
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 bachelor's 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)
#LI-KO1
Cytel Inc. is an Equal Employment / ****. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
Bloemfontein, South Africa
Bellville, South Africa
Centurion, South Africa
Full time
R
Job Overview
Provide advanced technical expertise to develop, maintain, and support programs that meet internal and external client needs. Plan and lead the development of project-related solutions covering the full scope of statistical programming activities. Serve as a technical resource within the Statistical Programming department.
Essential Functions
- Plan, perform, test, and document programs used to produce statistical tables, figures, and listings.
- Program analysis databases (derived datasets) and manage data transfers for internal and external clients.
- Plan and perform database quality control and validation activities, as required.
- Program the integration of databases from multiple studies or data sources.
- Develop and maintain programming documentation, including plans and specifications, as appropriate.
- Provide advanced technical expertise to internal and external stakeholders and independently deliver project solutions to teams and the department.
- Plan, develop, implement, and validate new processes, technologies, macros, and applications.
- Fulfill project responsibilities at the level of statistical team lead for single studies, under supervision.
- Understand project Scope of Work, estimate completed effort, and manage out-of-scope activities for single studies.
- May manage budgets and resource requirements, and provide revenue and resource forecasts for single studies.
- May be required to understand and apply budgeting and quoting assumptions.
- Provide training, mentorship, and guidance to junior and newly onboarded staff.
Qualifications
- Master's degree in Computer Science or a related field with a minimum of one year of relevant experience, or
- Bachelor's degree in Computer Science or a related field with a minimum of two years of relevant experience, or
- An equivalent combination of education, training, and experience.
- Knowledge of statistics, programming, and/or the clinical drug development process.
- Working knowledge of computing applications, including Base SAS, SAS/STAT, and SAS Macro Language.
- Strong organizational, interpersonal, leadership, and communication skills.
- Ability to manage multiple tasks and projects effectively.
- Excellent attention to detail and accuracy.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
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 is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be