Lead Biostatistician - NDA Submissions & SAPs
Datawise Inc
Datawise Inc. in New Jersey is seeking a Senior Biostatistician to lead statistical activities for clinical trials, including randomization, SAP development, and reporting. You will review CRFs and data management docs, and mentor junior biostatisticians while collaborating with clients. The role emphasizes NDA submissions, end-to-end statistical workflows, and strong SAS/R expertise within a fast-paced environment. A doctorates not required but extensive experience is valued. #J-18808-Ljbffr Datawise Inc
- Syneos Health is seeking a Principal Biostatistician for Medical Affairs across the UK, Ireland, Poland, Greece, Hungary, Romania, Ukraine,... ...provide statistical input across the lifecycle of trials, develop SAPs, and collaborate with sponsors and cross-functional teams to...SAP
- ...inVentiv Health Commercial LLC is seeking a Principal Biostatistician (Biomarker Analyst - US based) to lead biomarker statistics across oncology studies and... ...the trial lifecycle. The role emphasizes planning, SAP development, data analysis, and reporting of biomarker...SAP
- ...Job Description - Biostatistician Job Title: Biostatistician Location: [City... ...Design statistical analysis plans (SAPs) for clinical trials and observational... ...analyses. Contribute to regulatory submissions (FDA, EMA, PMDA, etc.) by preparing statistical...SAPInterim roleRemote workFlexible hours
- ...The Senior Biostatistician provides statistical support and leadership for oncology clinical... ...through final reporting and regulatory submission. Contribute statistical input to study... ...requirements. Experience developing or reviewing SAPs, protocols, and statistical outputs....SAPInterim roleRemote work
- Syneos Health seeks a Principal Biostatistician RWE (NA Only) to lead RWE studies and health economics analyses... ...oversee statistical design, create SAPs, and guide biostatistics teams in... ...-quality analyses for regulatory submissions. The role emphasizes RWD data sources...SAPRemote job
- Gan & Lee Pharmaceuticals is seeking a Biostatistician for their New Jersey location to provide statistical input for product development... ..., analysis, and data presentation to support regulatory submissions. Ideal candidates must have an MS in Biostatistics or related...
- Principal Biostatistician (Biomarker Analyst - EMEA and US BASED) Job Responsibilities... ...Statistical Analysis Plans (SAPs), including development of... .... May be responsible as Lead Biostatistician for the... ...or multiple projects (e.g., submissions, integrated analyses), attend...SAPContract work
$113 per hour
...confidential client is seeking a Study Lead Statistician (SLS) to lead statistical activities... ...‑level activities such as regulatory submissions and publications. RESPONSIBILITIES... ...review, and contributions to protocols, SAPs, TFL shells, DMC charters, SDTM and ADaM...SAPRemote workMonday to Friday$90 - $100 per hour
...reports from previous oncology studies with minimal supervision by the lead statistician. Experience on executing post hoc analysis and... ...CRO programmers. Statistical activities include the development of SAP, shells and analysis specification files, statistical analysis...SAPContract workRemote work$130k - $220k
...Principal, BiostatisticianThe Principal, Biostatistician will own the statistical and quantitative work that connects clinical evidence to... ...design and regulatory statistical frameworks (ICH E9, estimands, SAP development)Track record of translating rigorous analysis into...SAPFull timeInterim roleLocal area- micro1 is seeking a Biostatistician contractor to support AI-assisted clinical research projects. You will apply statistical expertise to derive... ...), and strong SAS or R skills, with the ability to interpret SAPs and clearly document evaluation rationales for independent...SAPRemote jobFor contractors
- NYHelus Pharma in the United States is seeking a Biostatistician (Contractor) to support early-phase clinical development, primarily Phase 1 studies, reporting to the Director, Biostatistics. The role partners with Clinical Development, Data Management and CROs to ensure...Contract workFor contractors
- Syndax Pharmaceuticals in New York, NY is seeking an experienced Contract Biostatistician to lead statistical efforts supporting Medical Affairs and Real World Evidence (RWE). The successful candidate will collaborate with teams to enhance evidence generation strategies...Remote jobContract work
- A leading global CRO is seeking a Principal Biostatistician to provide scientific and statistical leadership in early-phase studies focused on PK/PD. Responsibilities include leading study design, conducting analyses, and mentoring team members. Required qualifications...Remote work
- ...most innovative thinkers in FinTech as we lead the evolution of financial technology. If... ...filings, ensuring accurate and timely submissions Coordinating internal and external audits... ...ERP systems and an experienced Excel user; SAP experience strongly preferred, Workday experience...SAPFull timeContract workWork at officeLocal areaImmediate startFlexible hours2 days per week
- ...A leading life sciences company is seeking a Regulatory Operations Manager to oversee the publishing of deliverables for electronic submissions to health authorities. The role involves vendor oversight, quality control of submission-related documents, and ensuring compliance...Remote work
- What We Are Looking For We are hiring a Lead Financial Controller who will own the financial... ...filings, ensuring accurate and timely submissions coordinate internal and external audits,... ...Comfortable working with ERP systems; SAP experience strongly preferred, Workday experience...SAPWork at officeLocal areaFlexible hours2 days per week
- ...molecular diagnostic tests. As a Senior Biostatistician , you will leverage your applied... ...plans, and reports to support regulatory submissions and internal decision-making. Problem-Solving... ...and more targeted interventions that lead to longer, healthier lives. WHAT WE OFFER...Work at officeImmediate startRemote workWorldwide
- ...Biostatistician / Data Scientist – Medical Analytics & Exploratory Data Sciences (Contract) Location: Remote, US Overview: We are seeking... ..., reimbursement strategy, and European regulatory submissions, with a focus on patient‑reported outcomes (PRO) and real‑world...Contract workRemote work
- ...A leading analytics firm is seeking a talented Biostatistician or Data Scientist to support exploratory analyses for publications and regulatory submissions. This position requires strong SAS programming skills and an advanced degree in a relevant field. Ideal candidates...Remote work
- ...filings, ensure total accuracy in AI-driven data extraction, and lead annual audit preparations.Stakeholder Communication & Leadership:... ...on experience with enterprise financial systems such as NetSuite, SAP, Workday, Coupa, Zip, or similar ERP/procurement platforms....SAPWeekly payVisa sponsorship
- ...Therapeutics in San Diego is seeking an Associate Director of Medical Writing to oversee regulatory submissions and ensure compliance with writing standards. You will lead a team of writers and collaborate with cross-functional partners to deliver high-quality documents...
$65k - $80k
...Precision Marketing group, seeks a Regulatory Operations Specialist in New York City for hybrid work. You will manage regulatory submission workflows, ensure accuracy, and collaborate with cross-functional teams to meet client MLR requirements. The role requires 2-4 years...Work at office- Xeris Pharmaceuticals Inc. is seeking a Manager, Regulatory Affairs to lead regulatory activities supporting global clinical trials across all phases. You will prepare and review submissions (INDs/CTAs), help shape regulatory strategy, and interact with internal and external...
- ...and processes4+ yrs. experience in Power Exchange CDC tools and should have worked extracting data from different source system like SAP, Oracle, and AS400 etc.Good Knowledge on DWH conceptsExperience in developing and deploying Informatica in Unix and Oracle 11g database...SAPPermanent employmentFull timeH1b
- We Are:Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations... ...some of the coolestprojects you can imagine.The Work:The Senior SAP OTC & GTS Workstream Lead is responsible for leading the design,...SAPFull timeWork experience placementLive inWork at officeLocal areaShift work
$158.31k - $193.49k
...Healthcare Revenue Cycle Advisory and Solution Engineering Team Lead reports to the PMI Healthcare Head and operates as a player/coach... ...Oracle Health (Cerner), Meditech, athenahealth, Workday, Oracle ERP, SAP, Infor, or similar healthcare and financial platforms.Experience...SAPFull timeLocal area- ...role requires 6-10+ years of global payroll experience, knowledge of payroll regulations, and proficiency in systems like Workday or SAP. The Global Payroll Manager will handle end-to-end payroll processing, manage vendor relationships, and work closely with internal business...SAP
$134.5k - $265.1k
Position Summary Manager - Commodity Solutions Lead - Enterprise Operations & RiskOur Deloitte Regulatory, Risk & Forensic team... ...integrating RightAngle with enterprise resource planning systems such as SAP or OracleThe wage range for this role takes into account the wide...SAPLocal area- ...Job Description Job Description GRC Lead requires: Hands-on experience implementing or managing audit technology platforms, specifically... ...Matrix (RCM) development. Expertise in ERP controls for SAP, Oracle, and NetSuite. Solid understanding of IT General...SAP
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Lead Biostatistician - NDA Submissions & SAPs. Be the first to apply!


