Senior Statistical Programmer /Analyst Consultant (3 days Hybrid at Malvern PA) at ClinChoice

<p>&nbsp;</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> Senior Statistical Programmer Consultant</strong>&nbsp;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;">ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.&nbsp;</span><br><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Location: 3 days hybrid at Malvern PA</strong></span></p> <p style="line-height: 1.2;"><span style="text-decoration: underline; font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Job Summary</strong></span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">The contract Senior Statistical Programmer is a member of the Biometrics Department within the Research and Development (R&amp;D) organization who supports Statistical programming work in accordance with corporate standard operating procedures (SOPs), GCP, 21 CFR and ICH guidance.</span></p> <p style="line-height: 1.2;"><span style="text-decoration: underline; font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Responsibilities</strong></span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Programing for clinical trials:</strong></span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Program and validate derived datasets, tables, figures, listings. Process data from the external sources. &nbsp;</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Perform ad hoc exploratory analyses for publications and programming support other functions of Research and Development or other organizations. </span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Oversee programing work/deliverables from CROs.</span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages.</span><br><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Electronic submissions:</strong></span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Program and validate CDISC compliant deliveries for the electronic submissions. </span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Support in the creation of supporting documentation for submissions.</span><br><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Project Management:</strong></span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ensure programming deliverables are on time and of high quality. </span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Help managing internal contractors and external vendors.</span><br><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Standards and Guidelines:</strong></span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Participate in development of departmental working instructions and guidelines. </span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Help in creation of enhanced functions/macros and utilities.&nbsp;&nbsp;</span></p> <p style="line-height: 1.2;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong><span style="text-decoration: underline;">Qualification &amp; Experience&nbsp;</span></strong></span></p> <ul> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Bachelor or Master degree in Computer Science, Mathematics, Engineering, Medical or related discipline.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">BS with more than 5 or MS with 3 years of experience in statistical programming (SAS, R) in the pharmaceutical industry.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Working knowledge of SAS and its various components.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Knowledge of R programming in clinical trials</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Familiarity of the drug development process.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Strong SAS and SAS Macro language skills.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">R programming skils in clinical trials</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Strong knowledge of industry standards.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ability to work on data integrations (ISS and ISE).</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Strong oral and written communication skills. Ability to communicate details of the analysis to other team members with less technical experience.</span></li> </ul> <p style="line-height: 1.2;">&nbsp;</p> <p style="line-height: 1.2;">&nbsp;</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.&nbsp; 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.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</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.&nbsp;&nbsp; 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 style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong><span data-teams="true">#LI-TT1 #LI-Remote #senior#contract</span></strong></span></p> <p>&nbsp;</p> <p>&nbsp;</p>