Principal Statistical Programmer
$98.2k - $273.2kIQVIA LLC
Position Summary We are seeking a Principal Statistical Programmer to provide end‑to‑end statistical programming support across clinical development programs. This role requires deep technical expertise, leadership, and hands‑on delivery, covering SDTM, ADaM, TLF development, and regulatory submission support. The Principal Statistical Programmer will serve as a subject matter expert, ensure high‑quality deliverables, and contribute to programming standards and best practices. Key Responsibilities Provide end‑to‑end statistical programming support for clinical studies from study setup through submission Lead and perform development and validation of SDTM datasets, ADaM datasets, and Tables, Listings, and Figures (TLFs) Ensure all deliverables are compliant with CDISC standards and regulatory requirements Support regulatory submissions (e.g., FDA, EMA), including define.xml, submission‑ready datasets, and reviewer’s guides Serve as a Principal‑level programmer, providing technical leadership and guidance to other programmers Contribute to and help maintain programming standards, macros, and validation processes Review and approve programming deliverables to ensure accuracy, consistency, and quality Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams Proactively identify risks and propose efficient, compliant solutions within timelines Required Qualifications Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field Extensive experience as a statistical programmer, with demonstrated Principal‑level responsibilities Strong hands‑on experience with SDTM and ADaM dataset development, TLF programming, and regulatory submission deliverables Expert proficiency in base SAS and advanced SAS with good hands‑on SAS Macros In‑depth knowledge of CDISC standards, regulatory guidelines, and submission requirements Proven ability to manage complex studies independently from start to finish Benefits & Compensation The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00. The actual base pay offered may vary based on a number of factors including job‑related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part‑time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. Equal Opportunity Employer IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. #J-18808-Ljbffr IQVIA LLC
- ...biostatistics which include the development of analysis datasets, and statistical summaries. Oversee the efficient, accurate, and timely... ...training programs; serve as a mentor to junior level programmers. May attend related continuing education programs, professional...SuggestedWork at officeFlexible hours
$98.2k - $273.2k
...Exposure-response analysis PK parameter pooling Experience 8+ years of statistical programming experience in the pharmaceutical or CRO environment. Demonstrated experience as a Lead Programmer or technical lead. Prior experience working in an FSP engagement model...SuggestedFull timePart time- ...development programs (with a focus on long-acting medicines) and providing medical governance for Phase 1-4 studies. Principal Statistical Programmer You will lead programming activities for one or more studies, ensuring high‑quality development, validation, and delivery...SuggestedLocal area
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...Manager to oversee clinical activities and staff. The role involves ensuring compliance with treatment protocols, analyzing patient statistics, and conducting meetings. Candidates must have a postgraduate degree and be licensed as an occupational therapist or speech...$76.81k - $130.58k
...focused on local journalism, disinformation, digital platforms, and related policy areas. Lead study design, primary data collection, statistical analysis, and report writing and editing. Construct, manage, and analyze large databases; conduct qualitative and quantitative...Full timeFor subcontractorLocal areaRemote work- Novartis is seeking a Validation Lead at its Morrisville site to drive validation strategy across process, cleaning, packaging, and ongoing verification activities. You will own the Validation Master Plan and collaborate with Engineering, Quality, Analytical Science & Technology...
- Novartis Group of Companies is seeking a Validation Lead in Morrisville, NC to shape the site's validation strategy across process, cleaning, packaging, and ongoing verification activities. You will own the Validation Master Plan, deliver robust data for product launches...
$273.2k - $358.6k
...drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive...$120.97k
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