Senior Manager, Statistical Programming
3 weeks ago
The Senior Manager Statistical Programming will act as statistical programming lead for various clinical studies. You will collaborate with Biostatisticians and Statistical Programmers and ensure high quality and timely statistical programming deliverables. You also will perform oversight on the counterpart from vendors. You will report to Senior Director, Statistical Programming.
You should demonstrate leadership competencies and have extensive experience in SAS programming within biopharmaceutical clinical trials environment and in-depth understanding of CDISC standards and drug development principles, preferably in solid tumor therapeutic area.
Collaborate closely with Biostatistics, Data Management, Medical, Safety, Clinical Research, Clinical Operation, and other functions within Bicycle Therapeutics to address their needs for statistical programming support
Develop and validate programming specification for table, listing, and figure
Develop and validate SAS program that generate table, listing, and figure
Apply knowledge of CDISC SDTM and ADaM to develop and validate SDTM annotated CRF, SDTM mapping specification and ADaM specification
Develop and validate SAS program that generate SDTM and ADaM dataset
Create and validate files necessary to support electronic submission in eCTD format
Conduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publication
Support development of CRF, edit check, review of Data Transfer Specification, and any other collaborations with Data Management function
-
Senior Statistical Programmer
3 weeks ago
Cambridge, United States Prometrika LLC Full timeJob DescriptionJob DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the...
-
Principal Statistical Programmer
3 weeks ago
Cambridge, United States Prometrika LLC Full timeJob DescriptionJob DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the...
-
Senior Clinical Data Manager
4 weeks ago
Cambridge, Massachusetts, United States AL Solutions Full timeGeorge Higginson is currently searching for a highly experienced Senior Clinical Data Manager for the up-and-coming CRO, specialising in Oncology. The Senior Clinical Data Manager is responsible for the oversight and management of data management activities to ensure high quality data collection tools, database design and oversight of data management...
-
Sr Statistical Programmer
1 month ago
Cambridge, United States Connect Life Sciences Full timeActs as the lead programmer or project lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets.Assumes leadership responsibility as a contributing member of a multidisciplinary...
-
Senior Clinical Data Manager
4 weeks ago
Cambridge, Massachusetts, United States AL Solutions Full timeAshley Smith-Brown is partnered with a rapidly growing International Life Science partner who are looking for an experienced Senior Clinical Data Manger to join their expanding Biometrics team. Position Overview: Ashley Smith-Brown is seeking an experienced and motivated Senior Clinical Data Manager to join their growing team. In this role, you will play a...
-
Senior Manager, Quality
4 weeks ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Description Senior Manager, Quality provides Quality oversight for Bicycle’s development programs, ensuring compliance with applicable ICH GCP and GLP standards and global regulations. As an integral member of the team tasked with product development, the position serves as a Quality and compliance business partner, engaging with multiple...
-
Senior Manager, Regulatory Affairs
3 weeks ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Senior Principal Biostatistician
6 days ago
Massachusetts, United States Warman O'Brien Full timeSenior Principal Biostatistician | Pioneering Global CROJoining a Global Leader, you'll be at the forefront of healthcare innovation, driving clinical research forward from molecule discovery to life-saving medicine. We are the trusted partner of choice for pharmaceutical, biotechnology, medical device, and government organizations worldwide.What you'll be...
-
Senior Admin Assistant
4 weeks ago
Cambridge, Massachusetts, United States Global Channel Management, Inc Full timeSenior Admin Assistant needs 3 years of experience in a professional work environment or in administrative/office management/coordinator position Senior Admin Assistant requires: Excellent customer service orientation, team-player attitude, and willingness to assist all groups at other sites. Proficient knowledge of Microsoft programs (Word, Excel,...
-
Senior Clinical Data Manager
4 weeks ago
Cambridge, United States AL Solutions Full timeJob DescriptionJob DescriptionGeorge Higginson is currently searching for a highly experienced Senior Clinical Data Manager for the up-and-coming CRO, specialising in Oncology. The Senior Clinical Data Manager is responsible for the oversight and management of data management activities to ensure high quality data collection tools, database design and...
-
Senior Biostatistician
3 weeks ago
Cambridge, United States Prometrika LLC Full timeJob DescriptionJob DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the...
-
Senior SAS Programmer
3 weeks ago
Cambridge, United States IntePros Full timeRESPONSIBILITIES:Provide subject matter expertise in designing and developing clinical trials, protocols, and case report forms.Offer technical support and expert advice to internal and external sponsors.Lead and influence ongoing clinical studies by supporting statistical and non-statistical analyses.Implement programming and project standards in accordance...
-
Senior SAS Programmer
3 weeks ago
Cambridge, United States IntePros Full timeRESPONSIBILITIES:Provide subject matter expertise in designing and developing clinical trials, protocols, and case report forms.Offer technical support and expert advice to internal and external sponsors.Lead and influence ongoing clinical studies by supporting statistical and non-statistical analyses.Implement programming and project standards in accordance...
-
Senior SAS Programmer
3 weeks ago
Cambridge, United States IntePros Full timeRESPONSIBILITIES:Provide subject matter expertise in designing and developing clinical trials, protocols, and case report forms.Offer technical support and expert advice to internal and external sponsors.Lead and influence ongoing clinical studies by supporting statistical and non-statistical analyses.Implement programming and project standards in accordance...
-
Senior Product Manager, HCP Marketing
2 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeJob Description About This Role Reporting to the Sr. Director of HCP Marketing, the Senior Product Manager, HCP Marketing will drive key HCP marketing initiatives to drive growth for Biogen’s MS brands. What You’ll Do • Ensure specific HCP initiatives including marketing programs and campaigns are executed effectively, efficiently, within...
-
Biomarker Study Manager, Senior Manager
2 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeJob Description About This Role This role is responsible for clinical study bioanalytical and biomarker operations management. The bioanalytical and biomarkers study manger is a member of the clinical study team and will contribute to study start up, sample testing, data delivery and CRO management as it relates directly to supporting the PK, ADA and...
-
Lead Program Manager
4 weeks ago
Waltham, Massachusetts, United States Dynatrace Full timeJob Description At Business Insights we are seeking a highly motivated and experienced Program Manager Lead to join our team. In this role, you will play a crucial part in driving our overall business strategy by leading strategic programs and collaborating with other program and project managers. You will work closely with senior leadership to translate...
-
Academic Programs and Training Manager- Remote
3 weeks ago
Shrewsbury, Massachusetts, United States University of Massachusetts Medical School Full timeOverview: Under the direction of the Senior Director of Operation or designee, the Academic Programs and Training Manager will be charged with managing membership services, training, educational and research projects, and events including an annual conference in support of the Academic Consortium on Criminal Justice Health (ACCJH). This a large association...
-
Senior Manager, Medical Coding
1 week ago
Cambridge, United States Agios Pharmaceuticals Full timeSenior Manager, Medical Coding Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient...
-
Cambridge, Massachusetts, United States Philips Full timeJob TitleSenior Program Manager, Exploratory Innovation Teams (XITE)Job DescriptionSenior Program Manager, Exploratory Innovation Teams (XITE)We are seeking an entrepreneurial individual with strategy and project management experience to support the Exploratory Innovation Teams (XITE) program and define strategic priorities for the Research organization. In...