Description: The Study Lead Statistician SLS for product facing work is responsible for leading statistical activities of clinical studies. The SLS works closely with cross-functional team members to ensure their clinical studies are appropriately planned have the required statistical power for success comply with regulatory requirements and standards and maintain statistical as well as operational integrity throughout the life of the study. The SLS works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy. The SLS also works closely with the Study Statistician who performs all the operational activities related to the statistics-related deliverables. The SLS is responsible for the integrity and quality of their study. The SLS also supports product level activities that could include regulatory activities as well as publication work. Core responsibilities: Provide statistical guidance review and contribution to protocols SAPs TFL shells DMC Charters SDF specifications SDTM and ADaM randomization specifications other key-study related documentation protocol deviations data quality review and other communications. Attend and be a contributor at Clinical Study Team Meetings. Attend meetings for and provide statistical input into cross-functional study start-up activities including but not limited to CRF development database specifications review database development IVRS specification review. Initiate cross-functional team meetings as necessary e.g. SAP review TFL shell review TFL review. Provide statistical guidance review and be responsible for statistical analysis of individual studies/projects. Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints programmatically. Perform data-driven modeling during clinical studies. Coordinate the creation of required outputs for Dose Level Review Meetings DLRMs as well as coordinate and participate in the DLRM. Review TFLs created by statistical programming for consistency and accuracy. Author analysis reports such as Flash Memo and results section of the CSRs. Collaborate with the study programming team for study deliverables. Manage timelines for all statistics-related deliverables by working with the cross-functional team members e.g. programmers study statisticians clinical data managers medical writers. Additional Skills & Qualifications: Masters degree in Statistics/Biostatistics or other subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research or PhD degree with 5 years experience. Demonstrated ability in presenting results and defending statistical findings study design and analysis to internal audiences study/product team and at external meetings such as investigator meetings steering committee meetings ad board meetings or regulatory meetings. Leadership of at least 3 clinical studies/projects end-to-end with minimal oversight. Life cycle drug development experience pre-clinical development clinical development and post-marketing. Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions working with clinical development colleagues in study management programming and IS. Demonstrated ability to influence decision making. Experience in adaptive clinical trials and innovative study designs. Experience in the utilization of Bayesian statistics in clinical trials. Proficient R programming skills conducting simulations and applying statistical concepts and methods based on complex study designs. + Most recent experience from sponsor not CRO + 4-5 years with one study/project on the Sponsor side, not CRO (looking for longevity as this role will be similar and the person will need to take complete ownership of one project) + Prefers someone from drug development (however, med device is not a red flag) About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.