Senior Biostatistician - Clinical Trials & Regulatory
Jobtailor
Jobtailor in Acton, MA seeks a biostatistician to design and analyze clinical trials and observational studies in collaboration with Clinical Operations, Medical Affairs, Regulatory Affairs, and R&D. You will develop SAPs, perform analyses in SAS, MATLAB, and R, and contribute to protocols, CRFs, and CSRs while ensuring regulatory compliance and supporting submissions and publications. #J-18808-Ljbffr Jobtailor
- ...Principal Biostatistician CSL's R&D organization is accelerating innovation to deliver... ...components of statistical contribution to a clinical development program. The Principal... ...statistical strategies for clinical trials and regulatory submissions within the program, and...RegulatoryWork experience placementWorldwide
- ...Principal Biostatistician Statistics & Data Corporation (SDC), a... ...Arizona, delivering top-tier clinical trial services to pharmaceutical,... ...studies and provide senior level peer review of work being... ...participating in meetings with drug regulatory agencies as required....RegulatoryFull timeContract workFlexible hours
- ...PharmaceuticalsSelling Points Lead impactful clinical trials advancing neuropsychiatric therapies in... ...innovation. Engage globally with regulatory authorities and thought leaders.Job DescriptionSenior... ...Clinical Development OverviewThe Senior Medical Director Clinical Development...SeniorRegulatory
$104.1k - $156.15k
...Job Summary The Biostatistician will play a critical role in the design, analysis, and interpretation of clinical data to support product development, regulatory submissions, and publications. This position... ...Design and analyze clinical trials and observational studies in...RegulatoryFull timeWork at office- Responsibilities Design and analyze clinical trials and observational studies in collaboration with Clinical Operations, Medical Affairs, Regulatory Affairs, and R&D Develop statistical analysis plans (SAPs) and perform statistical analyses using SAS, MATLAB, and R...Regulatory
- ...but not limited to, the following: Reviewing Clinical Operations documents such as clinical trial agreements (CTAs) May be asked to assist in the... ...responsibilities Knowledge and understanding of ICH/GCP and regulatory guidelines/directives, especially ICH E6 R1 and R2...SeniorRegulatoryContract workWork at office
$252k - $269k
This Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes... ...compliance across global clinical trials. This leader ensures the... ...anticipate and respond to evolving regulatory expectations. Responsible for the Clinical...SeniorRegulatoryContract workWork at officeLocal areaWorldwideFlexible hours3 days per week$138k - $190k
Job DescriptionRole Summary: The Senior Manager, Clinical Procurement is responsible for driving sourcing... ...supporting global clinical trials and development programs. This role partners... ...clinical trialsKnowledge of GxP, regulatory requirements, and clinical compliance...SeniorRegulatoryContract work$286.69k - $307.98k
...Zenas is a clinical-stage global biopharmaceutical company committed... ...! Position Summary The Senior Medical Director, Clinical Development... ...for global clinical trials across all phases of development... ...Opinion Leaders and Investigators, Regulatory Authorities, Patient Advocacy...SeniorRegulatory- Senior Audit Associate - HybridPosition OverviewThe Senior Audit Associate will play a crucial role in conducting audits for our clients, ensuring compliance with regulatory requirements and internal policies. This position involves leading audit engagements, mentoring...SeniorRegulatory
$120k - $160k
...transduction for gene and cell therapy clinical trials and are proud to be a part of the process... ...part of that team. Job Summary The QC Senior/Principal Scientist for Analytical... ...with company policies and procedures and regulatory guidelines. Essential Job Functions Ability...SeniorRegulatoryImmediate startVisa sponsorship$137k - $215.27k
...for innovative medicines in clinical development. The Sr, Mgr, Planning... ..., translating clinical trial protocol information into a study... ...supply."ACCOUNTABILITIES:The Senior Manager, Planning Lead will... ...country investigational product regulatory requirements for delivery of...SeniorRegulatoryMinimum wageContract workTemporary workLocal area- ...Description Job Description 37504289 Remote Senior Manager, Clinical Supply Chain 6 Months Contract... ...addition, working closely with CMC, Regulatory Affairs, Quality Assurance, Clinical... ...Product (IP) for clinical trials. Requirements: BS/BA degree (Masters...SeniorRegulatoryContract workLocal areaRemote work
$146k - $161k
...inclusive, and positive company culture. Job Title: Clinical Trial Manager/Senior Clinical Trial Manager Location: Hybrid 3 days/week if... ...culture. Role Overview: Will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating...SeniorRegulatoryWork at officeRemote work3 days per week- ...Monitor is a key member of the Clinical Development team responsible... ...communication of clinical trial data. Working closely with cross... ...development, study conduct, regulatory activities, and data-driven decision... ...-based recommendations to senior leadership and cross-...SeniorRegulatory
- ...Senior Clinical Document Management Specialist Integrated Resources, Inc is a premier staffing... ...for the management and oversight of Trial Master File (TMF) records from set-up through... ...of documentation required for regulatory agency inspection and internal audits....SeniorRegulatoryFlexible hours
$284.25k
...meaningful impact in the real world.The Senior Medical Director, Oncology Clinical Development - Lung is a senior... ...contributing to complex clinical decisions, regulatory interactions, and external... ...Interpretation, Clinical Pharmacology, Clinical Trial Designs, Clinical Trials Monitoring...SeniorRegulatoryFull timeWork at officeLocal areaRelocation2 days per week- Senior Medical Affairs Specialist - Global Medical Communications If you're an experienced... ...who can confidently interpret clinical evidence, influence cross-functional strategy... ...stakeholders. You'll partner with Clinical, Regulatory, and Commercial leadership to ensure the...SeniorRegulatoryWorldwide
$284.63k
GSK is seeking a highly skilled Senior Medical Director, Clinical Development, Neurodegeneration to provide... ..., ensuring clinical excellence, regulatory compliance, and operational efficiency... ...assets for clinical studies, and perform trials through to submission for approvals....SeniorRegulatoryFull timeWork at officeLocal area2 days per week- ...DescriptionThe Contract Biostatistician will be responsible... ...statistical aspects of clinical development programs.... ...experience in a clinical trial setting (biotech,... ...Understanding of clinical / regulatory concepts for at least... ...level: Mid-Senior LevelIndustry: PharmaceuticalsRegulatoryContract workImmediate start
$86k - $105k
...of disease. The company is advancing clinical programs for Duchenne muscular dystrophy... ...Facebook. Role Summary: The Senior Clinical Trial Associate (CTA) is a key member of the... ...initiation visit materials, essential regulatory documents, study plans, recruitment materials...SeniorRegulatoryWork at officeLocal area- ...Senior Clinical Trial Manager Lumicell is seeking an experienced Senior Clinical Trial Manager to lead operational execution of post-market... ..., Pharmacovigilance, Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, Medical Affairs, Commercial Operations...SeniorRegulatoryContract workFor contractors
$170k - $190k
...lives of patients who need it most. The Senior Clinical Project Manager will provide... ...initiation, execution and reporting of clinical trials in accordance with ICH/GCP and all... ...Global Medical Safety, GCP Quality and Regulatory staff as well as Clinical Research Organizations...SeniorRegulatoryContract workWork at officeLocal area$284.63k
...DPosition SummaryYou will lead clinical development medical... ...operations, translational science, regulatory, safety, and commercial teams... ...experienced a Clinical Development Senior Medical Director to join the... ...in research, clinical trial methodologies, competitive environment...SeniorRegulatoryFull timeLocal areaRemote workRelocation2 days per week$284.25k
The Senior Medical Director, Oncology Clinical Development - GU will report to the Executive... ...oncology clinical trials in support of the successful... ...successful clinical development, regulatory filing and initial... ...professionals, biostatisticians, regulatory, executive staff...SeniorRegulatoryFull timeWork at officeLocal areaWorldwide2 days per week- ...Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development... ...and scientific principles, knowledge of compliance and regulatory requirements, AbbVies customers, markets, business operations...SeniorRegulatory
$317k - $369k
...mission is to deliver significant clinical benefit to a wide range of... ...Medical Director, the Senior Medical Director will serve as... ...(CDP) for successful global regulatory approval and market access for... ...key documents (e.g., Clinical Trial Protocols, Investigator's Brochures...SeniorRegulatoryHourly payFull timeContract workWork at officeLocal area3 days per week$170k - $187k
...Description TScan Therapeutics is a clinical-stage biotech seeking to revolutionize... ...cells and epitopes. We are looking for a Senior Clinical Trial Manager to support these studies. The... ..., company SOPs, and applicable regulatory requirements. Lead cross-functional...SeniorRegulatoryLocal areaFlexible hours$340k - $360k
...critical responsibilities in the clinical department involved in the... ...indications. Key trial related responsibilities include... ...interact externally with key global regulatory authorities, industry and scientific... ...with and presenting to senior management and external audiencesAbility...SeniorRegulatoryWork at officeLocal areaFlexible hours3 days per week$87 per hour
Senior Medical Affairs Specialist Location: Acton, MA (Hybrid - 3 Days Onsite Per Week)... ...communications, scientific strategy, and clinical data dissemination within the diabetes... ...compliance with medical, scientific, and regulatory standards. Analyze clinical evidence, treatment...SeniorRegulatoryContract workWork at office3 days per week
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