Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (……
This role then performs coding, debugging, testing, configuration, and analysis to develop or modify application programs. 10%: Up to 26 business days per year.…
Valid state issued Driver's License. Utilize superior communications skills to motivate staff and develop effective working relationships with peers, executives……
Work with JDS product and support teams to develop and implement product/service improvement strategies. Providing ad hoc external admin support to and content……
Doctorate degree (e.g., PhD, ScD, DrPH) in Biostatistics/Statistics, Data Science, Bioinformatics, Biological Sciences, Public Health, Math, or a closely……
And consumption in addition to designing and building test-driven development, reusable frameworks, automated workflows, and libraries at scale to support……
Stay up to date with changes in the programming field. The Senior Manager, Statistical Programming will apply programming methodology to summary and analysis of……
Collaborate with data scientists, laboratory scientists, the medical team, technologists and the regulatory team on study design, planning, data preparation,……
The consultant will develop programs for Human Capital Management (HCM), Financial Accounting (FI), and Material Management (MM) modules of SAP, provide ABAP……
Must be confident communicator, capable of presenting statistical analysis and technical concepts to non-technical users and senior leadership.…
The incumbent should be able to work independently implementing and executing the programming and project standards to support ongoing clinical studies and……
Experience managing outsourced programming activities and overseeing deliverables from CROs and contractors. Manage CROs and contractors, ensuring compliance,……
Must possess a full valid driver’s license and be insurable under our auto insurance policy. Work with HSE Managers, field teams, and operations to gather……
Lead/oversee optimization of statistical methods for the design, conduct, analysis, and reporting of clinical studies, and to address identified or potential……
Collaborate with our Business Systems Analyst, Project Manager, and cross-functional teams to understand software requirements, develop technical specifications……
The Director, Biostatistics, provides technical leadership and operational oversight for the development of clinical strategies, the design, implementation and……
WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the……
The CNC Programming Manufacturing Engineer is responsible to identify opportunities through analysis, manage project development from initiation to closure,……
Responsible for supporting the development and implementation of Front end, Back end, Mobile, and financial all-encompassing Web Applications and user……
Must have master’s degree (or foreign equivalent degree) in engineering (any field), science (any field), information systems, business or a closely-related……
Design & develop BW Data Model. Install and configure BOBJ presentation tools, integration of BW with Business Objects suite of products including Web……
Will develop project timelines, maintain regular reports, facilitate team planning meetings and ensure team members share appropriate information and tools.…
Exceptional business acumen and communication skills - effective written and verbal communication skills; able to express oneself clearly and in technical and……
Research, design, develop, configure and test SAP software applications per specifications in SAP ECC. High level of technical aptitude with the ability to……
Expected to manage their own tasks, take on small to moderate projects, and continue developing their technical proficiencies with current and emerging……
The Oracle Systems Analyst is a technical role responsible for the full life cycle development, implementation, production support, and performance tuning of……
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
Position leads complex studies in study design, statistical analysis and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems.
Responsibilities
Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines. Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
Qualifications
Education Qualifications
Master's Degree in statistics or biostatistics required PhD in statistics or biostatistics preferred
Experience Qualifications
8+ Years of relevant experience in the pharmaceutical industry with a masters degree required
5+ Years of relevant experience in the pharmaceutical industry with a PhD preferred
Travel Requirements
Ability to travel up to 10% of the time.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
The minimum salary is $168K and the max salary is $252K.
$168K – $252K/yr (Employer provided)
$210K
/yr Median
Basking Ridge, NJ
If an employer includes a salary or salary range on their job, we display it as "Employer Provided". If a job has no salary data, Glassdoor displays a "Glassdoor Estimate" if available. To learn more about "Glassdoor Estimates," see our FAQ page.
Working here doesn’t have to be a secret
Sign in to browse authentic reviews, anonymous ratings and salary data before you apply.