Statistical Programmer II

Parexel·
Remote
4w ago

Description

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we&#39;re committed to making a difference.</p><p></p><p></p><p><b>Statistical Programmer II (R Focus) – Mexico (Remote)</b></p><p></p><p><b>Join Parexel and make a meaningful impact on global health.</b></p><p></p><p>Parexel is seeking an <b>R-focused Statistical Programmer II</b> to join our team in Mexico, fully dedicated to a single sponsor. This is a <b>100% remote, full-time</b> opportunity offering the chance to contribute to high‑visibility clinical trials, grow your expertise, and enjoy long-term career stability.</p><p>In this role, you will provide technical programming expertise to support the analysis and reporting of clinical study data. Working with minimal supervision, you will handle a variety of programming activities and may also serve as a Statistical Programming Lead (or contribute to that role) for smaller, non‑complex projects.</p><p><b>At Parexel FSP, you’ll experience:</b></p><ul><li><b>Exceptional long-term career security</b></li><li>Opportunities to work with <b>leading global biopharma and biotech organizations</b></li><li>An <b>extensive pipeline</b> of impactful clinical research projects</li><li>A supportive environment that values work–life balance and professional growth</li></ul><p>Expect inspiring scientific challenges with room to enjoy life outside of work.</p><p></p><p><b>Key Responsibilities</b></p><ul><li>Assist in coordinating project start-up activities, including global program creation, tracking spreadsheets, and required documentation.</li><li>Continuously check your own work to ensure <b>first-time quality</b>.</li><li>Apply efficient programming techniques to produce derived datasets (e.g., <b>SDTM, ADaM</b>), tables, figures, and data listings of any complexity; perform QC for low–medium complexity datasets, tables, figures, and listings.</li><li>Assist in producing and QC’ing derived dataset specifications, process-supporting documents, and submission documentation.</li><li>Maintain and expand knowledge of both local and international regulatory requirements within clinical research.</li><li>Build expertise in <b>SAS </b>and gain an understanding of processes within other Parexel functional areas.</li><li>Provide relevant training and mentorship to colleagues and project teams.</li><li>Maintain complete and accurate study documentation according to <b>SOPs/Guidelines</b> to ensure traceability and regulatory compliance.</li><li>Ensure compliance with SOPs/Guidelines, <b>ICH-GCP</b>, and other applicable regulations (including 21 CFR Part 11); participate in internal/external audits and regulatory inspections as needed.</li><li>Proactively contribute to process and quality improvement initiatives.</li><li>Understand regulatory expectations related to industry technical standards (e.g., <b>CDISC, 21 CFR Part 11, electronic submissions</b>).</li></ul><p></p><p><b>Role-Specific Requirements</b></p><ul><li>Bachelor’s degree in <b>statistics, biostatistics, mathematics, computer science, or life sciences</b>.</li><li>Excellent analytical skills.</li><li>Intermediate proficiency in the <b>R programming language</b>.</li><li>Knowledge of programming and reporting processes.</li><li>Understanding of SOPs/Guidelines, <b>ICH-GCP</b>, and applicable regulations such as 21 CFR Part 11.</li><li>Ability to learn new systems and work effectively in an evolving technical environment.</li><li>Strong ability to manage competing priorities and adapt to change.</li><li>Proven success working as part of a <b>global team</b>.</li><li>Effective time management to meet daily metrics and team objectives.</li><li>Business and operational skills including customer focus, commitment to quality, and problem‑solving.</li><li>Strong understanding of <b>CDISC standards</b>.</li><li>Knowledge of statistical terminology, clinical tests, and protocol designs.</li><li>Excellent attention to detail with a commitment to quality.</li><li>Strong written and verbal <b>English communication</b> skills.</li></ul><p></p><p><b>Why Parexel?</b></p><p>At Parexel, we care deeply about our people — your expertise, your growth, and your passion are central to our success. We offer an open and collaborative work environment where you are empowered to thrive and advance your long-term career.</p><p>You’ll also have opportunities to expand your responsibilities within your role or build your capabilities across related departments.</p><p>Parexel supports clinical studies across the full range of therapeutic areas and has longstanding partnerships with a broad client base. We have contributed to trials for most of today’s top 50 best‑selling drugs, while also supporting innovative niche therapies essential to patient well‑being.</p><p>As a Statistical Programmer II, you’ll be an influential contributor within a dedicated and highly collaborative global team.</p>
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Parexel

CRO

LocationMA - Boston
Employees10001-50000
Open Jobs281
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Pipeline

Olaparib tabletsN/A
Observational Study of Characteristics, Treatment and Outcomes With Severe Asthma in the United StatN/A
NoneN/A
DeflazacortN/A
T790M Mutation Positive 2nd Line STandard of cAre RegistryN/A