<p> </p><p> </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 dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a <strong>Sr Principal Statistical Programmer-Oncology </strong>on a permanent basis. </span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!</span></p><p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong><u>Responsibilities</u></strong></span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Key responsibilities and skills may include, but are not limited to:</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Programming edit checks for Data Management with SAS.</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Create tables, listings and figures for clinical study report.</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Independently annotated blank CRF (acrf.pdf) with appropriate tools per FDA or CDISC guidelines.</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Create or QC SDTM specifications and SDTM datasets.</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Create or QC ADaM specifications and ADaM datasets.</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Create or QC define.xml or define.pdf</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf)</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Serve as team leader for one/more Programming groups.</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Independently coordinate and manage the preparation, execution, reporting and documentation of projects within a Programming group.</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Manage and coordinate the integration of data across studies in support if ISS and ISE and electronic submission deliverables.</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Following industry standards and be a mentor to other Programming leads or managers.</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Manage programming team. Take initiatives and follow through to develop the Programming team. Dare to lead.</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Be a role model for team members.</span><br><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong><u>Qualifications</u></strong></span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Bachelor’s degree in computer science, statistics or related scientific disciplines with 10+ year clinical programming experience; Master’s degree in computer science, statistics or related disciplines with 9+ year of clinical programming experience;</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Working knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Good understanding of clinical drug development process</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Detail oriented</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Strong communication skills and coordination skills</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">• Good leadership skills</span></p><p style="line-height: 1.2;"> </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#Permanent</span></strong></span></p><p> </p>