Principal Biostatistician for inhouse project (Permanent role) at ClinChoice

<p></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;">ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Clinical Project Manager II to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.</span><br><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">We are seeking a highly skilled <strong data-start="361" data-end="397">Principal Statistician</strong> to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.</span></p> <p style="line-height: 1.2;" data-start="329" data-end="692"><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> <h3 style="line-height: 1.2;" data-start="694" data-end="720"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Key Responsibilities</span></h3> <ul data-start="721" data-end="1606"> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="721" data-end="833"> <p data-start="723" data-end="833"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Lead and provide statistical support for clinical studies, primarily within <strong data-start="799" data-end="831">Immunology or any therapeutic areas</strong></span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="834" data-end="940"> <p data-start="836" data-end="940"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Act as the <strong data-start="847" data-end="868">lead statistician</strong> on assigned studies, overseeing statistical strategy and deliverables</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="941" data-end="1136"> <p data-start="943" data-end="998"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Author and review key statistical documents, including:</span></p> <ul data-start="1001" data-end="1136"> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1001" data-end="1038"> <p data-start="1003" data-end="1038"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Statistical Analysis Plans (SAPs)</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1041" data-end="1083"> <p data-start="1043" data-end="1083"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Analysis Database Specifications (ADS)</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1086" data-end="1136"> <p data-start="1088" data-end="1136"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Statistical sections of clinical study reports</span></p> </li> </ul> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1137" data-end="1233"> <p data-start="1139" data-end="1233"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1234" data-end="1342"> <p data-start="1236" data-end="1342"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1343" data-end="1414"> <p data-start="1345" data-end="1414"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Provide guidance and oversight to statistical programmers as needed</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1415" data-end="1528"> <p data-start="1417" data-end="1528"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1529" data-end="1606"> <p data-start="1531" data-end="1606"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs</span></p> </li> </ul> <h3 style="line-height: 1.2;" data-start="1608" data-end="1637"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Required Qualifications</span></h3> <ul data-start="1638" data-end="2205"> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1638" data-end="1700"> <p data-start="1640" data-end="1700"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">MS or PhD in Statistics, Biostatistics, or a related field</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1701" data-end="1768"> <p data-start="1703" data-end="1768"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong data-start="1703" data-end="1755">Strong experience in Immunology or any TA clinical studies</strong>&nbsp;</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1835" data-end="1994"> <p data-start="1837" data-end="1865"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Hands-on experience writing:</span></p> <ul data-start="1868" data-end="1994"> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1868" data-end="1905"> <p data-start="1870" data-end="1905"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Statistical Analysis Plans (SAPs)</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1908" data-end="1944"> <p data-start="1910" data-end="1944"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Analysis Database Specifications</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1947" data-end="1994"> <p data-start="1949" data-end="1994"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Reviewing and interpreting analysis results</span></p> </li> </ul> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="1995" data-end="2073"> <p data-start="1997" data-end="2073"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong data-start="1997" data-end="2032">SAS programming skills required</strong> (hands-on or strong working knowledge)</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="2074" data-end="2131"> <p data-start="2076" data-end="2131"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Excellent <strong data-start="2086" data-end="2129">written and verbal communication skills</strong></span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="2132" data-end="2205"> <p data-start="2134" data-end="2205"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Experience working in a CRO and/or pharmaceutical/biotech environment</span></p> </li> </ul> <h3 style="line-height: 1.2;" data-start="2207" data-end="2237"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Preferred Qualifications</span></h3> <ul data-start="2238" data-end="2397"> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="2238" data-end="2289"> <p data-start="2240" data-end="2289"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Experience leading Phase II–III clinical trials</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="2290" data-end="2336"> <p data-start="2292" data-end="2336"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Prior interaction with regulatory agencies</span></p> </li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;" data-start="2337" data-end="2397"> <p data-start="2339" data-end="2397"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Experience mentoring junior statisticians or programmers</span></p> </li> </ul> <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 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 style="line-height: 1.2;">&nbsp;</p> <p style="line-height: 1.2;">&nbsp;</p> <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;"></span></p>