<p></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...</span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ClinChoice is searching for a <strong>Principal Statistical Programmer Consultant </strong>to join one of our clients. </span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">The <strong data-start="1013" data-end="1049">Principal Statistical Programmer</strong> will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors. This role requires advanced expertise in <strong data-start="1256" data-end="1263">SAS</strong>, familiarity with <strong data-start="1282" data-end="1287">R</strong>, deep knowledge of <strong data-start="1307" data-end="1326">CDISC standards</strong>, and strong experience working on oncology studies and regulatory submissions.</span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"></span></p><h2 style="line-height: 1.2;" data-start="1412" data-end="1439"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong data-start="1415" data-end="1439">Key Responsibilities</strong></span></h2><h3 style="line-height: 1.2;" data-start="1441" data-end="1469"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong data-start="1445" data-end="1469">Technical Leadership</strong></span></h3><ul data-start="1470" data-end="1930"><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1470" data-end="1555"><p data-start="1472" data-end="1555"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Lead programming activities for oncology clinical trials across multiple studies.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1556" data-end="1646"><p data-start="1558" data-end="1646"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Develop, validate, and maintain <strong data-start="1590" data-end="1616">SDTM and ADaM datasets</strong> following CDISC guidelines.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1647" data-end="1750"><p data-start="1649" data-end="1750"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Oversee production of <strong data-start="1671" data-end="1711">Tables, Listings, and Figures (TLFs)</strong> for study reporting and submissions.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1751" data-end="1838"><p data-start="1753" data-end="1838"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Provide SAS programming expertise to support complex data derivations and analyses.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1839" data-end="1930"><p data-start="1841" data-end="1930"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Review and ensure traceability, consistency, and quality of all programming deliverables.</span></p></li></ul><h3 style="line-height: 1.2;" data-start="1932" data-end="1966"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong data-start="1936" data-end="1966">Project & Study Management</strong></span></h3><ul data-start="1967" data-end="2325"><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1967" data-end="2053"><p data-start="1969" data-end="2053"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Act as programming lead for assigned studies, managing timelines and deliverables.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="2054" data-end="2148"><p data-start="2056" data-end="2148"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="2149" data-end="2272"><p data-start="2151" data-end="2272"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to Kite’s programming standards.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="2273" data-end="2325"><p data-start="2275" data-end="2325"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Support integrated analyses including <strong data-start="2313" data-end="2324">ISS/ISE</strong>.</span></p></li></ul><h3 style="line-height: 1.2;" data-start="2327" data-end="2366"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong data-start="2331" data-end="2366">Regulatory & Submission Support</strong></span></h3><ul data-start="2367" data-end="2636"><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="2367" data-end="2493"><p data-start="2369" data-end="2493"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="2494" data-end="2568"><p data-start="2496" data-end="2568"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="2569" data-end="2636"><p data-start="2571" data-end="2636"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Contribute to responses for regulatory queries and data requests.</span></p></li></ul><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"></span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"></span></p><h2 style="line-height: 1.2;" data-start="2991" data-end="3021"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong data-start="2994" data-end="3021">Required Qualifications</strong></span></h2><ul data-start="3022" data-end="3593"><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="3022" data-end="3134"><p data-start="3024" data-end="3134"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="3135" data-end="3218"><p data-start="3137" data-end="3218"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong data-start="3137" data-end="3152">8–12+ years</strong> of statistical programming experience in pharma/biotech or CRO.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="3219" data-end="3259"><p data-start="3221" data-end="3259"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Expert-level proficiency in <strong data-start="3249" data-end="3256">SAS</strong>.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="3260" data-end="3322"><p data-start="3262" data-end="3322"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Strong understanding of <strong data-start="3286" data-end="3309">CDISC SDTM and ADaM</strong> standards.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="3323" data-end="3420"><p data-start="3325" data-end="3420"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Significant experience supporting <strong data-start="3359" data-end="3387">oncology clinical trials</strong> (hematologic or solid tumors).</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="3421" data-end="3513"><p data-start="3423" data-end="3513"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Experience supporting <strong data-start="3445" data-end="3471">regulatory submissions</strong> and preparing submission-ready outputs.</span></p></li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="3514" data-end="3593"><p data-start="3516" data-end="3593"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Excellent communication skills and ability to collaborate cross-functionally.</span></p></li></ul><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"></span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"></span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>The Application Process</strong></span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.</span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Who will you be working for?</strong></span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>About ClinChoice</strong></span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. </span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Our Company Ethos</strong></span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.</span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.</span></p><p style="line-height: 1.2;"><span class="ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak" style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong><br><span data-teams="true">#LI-TT1 #LI-Remote #Principal#Contract</span></strong></span></p><p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"></span></p><p></p>