Strategic Telecom Account Director – Sa & Emea

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.

**As a Principal Statistical Programmer, your responsibilities will include:**

• 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 / Affi…

Bloemfontein, South Africa
Bellville, South Africa
Centurion, South Africa
Full time
R

**Job Overview**

Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; Overview of financial management for data management activities; communications; and milestone deliverables. Perform role of Data Team Lead (DTL).

**Essential Functions**

• Gather Study Set up requirements through discussion and communication with relevant stakeholders.
• With Minimal guidance - support, overview of validation of new Device integrations.
• Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.
• Ensure that all the deliverables are of expected quality standards and meet customer expectations.
• With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).
• Support Training of New joiners.
• Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings.
• Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required.
• With Guidance manage & oversight the implementation of new technology / database revisions.
• Work closely with the programming team for process innovation and automation.
• Be compliant to trainings and eSOP reading.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
• Communication with Line Manager, and other team members across functions should be collaborative.
• Perform other duties as directed by Line Manager.

**Qualifications**

• Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management Req
• 3 -4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead. Pref
• English Fluency Spoken and English Advanced
• Advanced computer applications like Microsoft excel, word, Inbox etc Advanced
• Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced

**What You’ll Do**

• Lead data management for complex, global clinical trials from study setup to database lock.
• Serve as the main client contact for all data management deliverables.
• Oversee SAE, PK, and external data reconciliation and database deployment.
• Manage timelines, budgets, and resource allocation to meet customer expectations.
• Mentor junior data management staff and promote best practices.
• Drive process improvements and ensure regulatory and SOP compliance.

**What IQVIA Offers**

• Fully remote role - company equipment provided
• Competitive salary and performance-based incentives
• Career growth and learning opportunities through mentoring and internal mobility
• Inclusive, global culture focused on innovation and collaboration

**What to Expect After Applying**

• Recruiter video chat (20 min)
• Hiring manager interview (1 hour, MS Teams - Offer decisions are typically made within one or two weeks of the final interview.)

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 truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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