- Actalent (Thousand Oaks, CA)
- Description: The Study Lead Statistician SLS for product facing work is responsible for leading statistical activities of clinical studies . The SLS ... the Global Statistical Lead to ensure their study aligns with the overall product strategy.... strategy. The SLS also works closely with the Study Statistician who performs all the operational… more
- Randstad US (Newbury Park, CA)
- …and mathematical occupations + reference1065999 job details job summary: The Study Lead Statistician (SLS) for product facing work is responsible for ... study lead statistician . +... study lead statistician . + newbury park ,...leading statistical activities of clinical studies and should be able to work independently with… more
- Chiesi (Cary, NC)
- Lead Statistician Date: Sep 14, 2024 Department: Global Clinical Development Job Type: Direct Employee Team: R&D, Pharmacovigilance & Regulatory Affairs Contract ... statistics within the Clinical Development Plan (CDP) team, to support other statistician (s) involved in the project, ensuring consistent approach across studies … more
- Boehringer Ingelheim (Ridgefield, CT)
- …innovative, more efficient statistical methods for ready-to-use applications in BI studies and projects. Supports the BDS organization via project consultations, ... + Plans and conducts statistical trainings for statisticians and non-statisticians. + Lead or participate in cross-functional BI internal working-groups or lead … more
- Merck (North Wales, PA)
- …lead in the cross-functional teams for the strategic planning and execution for product development + Lead a team of statistical and/or programing staff ... personnel at regulatory agencies and with investigators concerning proposed or ongoing studies . + Lead research activities for innovative statistical methods and… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Position Summary** + CDLs are matrix leaders and managers who lead , develop, motivate and achieve results through teams; demonstrate a commitment to ... have a large impact on the business. Ensures clinical studies are aligned with target label indications and are...access goals + Serves as a matrix leader to lead , develop, motivate and achieve results through teams, and… more
- AbbVie (Florham Park, NJ)
- …functional area input for life cycle management of products. Support or lead communications between assigned product team(s) and functional management. ... Build/drive cross-functional relationship and collaboration. + Support/ Lead HTA submission for optimal reimbursement and product life-cycle management strategy… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …the Clinical Data Sciences - RWE organization of Gilead. **Job Responsibilities** + Lead or support RWE studies by designing, executing epidemiological ... protocols and statistical analysis plans using descriptive and complex study designs + Lead or support generation...of oncology research experience + Prior experience as a study epidemiologist or statistician for projects involving… more
- Sanofi Group (Cambridge, MA)
- …with the Global Project Head, Research Scientist, Clinical Pharmacologist, Biomarker Lead , Safety Medical Director, Statistician , Regulatory and other key ... and regulations as well as applicable standard operating procedures (SOPs). + Lead the study specific committees, eg, Independent Data-Monitoring Committee… more
- Medtronic (Irvine, CA)
- …to conduct studies relating to the life cycle of the product . + In development-phase projects, prepare the statistical component of protocols which meet ... helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in...and provide oversight and direct the activities for the statistician team. You will represent the function at internal… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …passionate drug developer, skilled manager and mentor, and an accomplished statistician with a strong ability to communicate technical concepts to non-statisticians. ... Bayesian designs for mid-phase programs, and rigorously controlled registrational studies for late-phase programs. The Executive Director ensures every development… more
- Sanofi Group (Cambridge, MA)
- …with regulatory agencies and key opinion leaders. **Key Accountabilities** + Acts as the lead statistician at project level for projects of small/medium size or ... with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for DSUR, SMTs) +...independent data monitoring committees + May act as the lead statistician at clinical trial level and… more
- Vera Therapeutics (Brisbane, CA)
- …diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion protein self-administered ... hoc analyses. * Attend SMT, and collaborate with the study statistician and other study ...the collaboration of cross-functional groups. * Able to effectively lead functional and cross-functional projects of varying scope and… more
- Amgen (Washington, DC)
- …worldwide. It's time for a career you can be proud of. **Accountabilities** *Develop, lead , and serve as the primary point of contact for the statistical program ... strategy for a portfolio of complex programs *Influence across product life cycle through developing statistically compelling Evidence Generation Plans (EGP) in… more
- AbbVie (North Chicago, IL)
- …Safety Statistical Analysis Plans (ISS SAPs). + Ensure consistency across documents (eg, PSSAP, study SAPs, ISS SAP). + Lead the development of safety data ... teams including members from Pharmacovigilance and Patient Safety (eg, product safety team physicians, epidemiologists, safety analysts), Statistical Programming,… more
- Ascendis Pharma (Palo Alto, CA)
- …You will be responsible for: + Representing the Statistical Programming team as study lead , focusing on data integrity, collaboration, and on-time deliverables. ... will work with highly skilled and passionate colleagues to advance our exciting product pipeline. As our new Senior Manager, Statistical Programming, you will manage… more