Manager/Sr. Manager, Biostatistics
Astellas Pharma Inc.
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
This position contributes to the design, analysis, and reporting of clinical studies, under direction of the Statistics Lead. As a member of study teams, the Biostatistics Manager is responsible for the quality and timeliness of all statistical deliverables of the assigned studies. May interact with vendor on progress of individual deliverables and instructs them on Astellas specifications. He/she is encouraged to complete these tasks independently in accordance with the project direction and standards.
To apply, please visit https://astellascareers.jobs/northbrook-il/managersenior-biostatistics-manager/533A4CE984224FF5921B2DC1795ECB65/job/
Link:
https://astellascareers.jobs/northbrook-il/managersenior-biostatistics-manager/533A4CE984224FF5921B2DC1795ECB65/job/
(REMOTE) Statistical Project Leader, Associate Director
Sanofi
Required Education/Experience:
PhD in statistics or related discipline with at least 6 years of pharmaceutical experience.
Demonstrated strong project/study management, interpersonal and communication skills.
Broad knowledge and good understanding of advanced statistical concepts and techniques.
Broad knowledge of pharmaceutical clinical development.
Broad experience in clinical development or post-marketing activities such as submissions, interactions with regulatory agencies or other external stakeholders.
Ability to be flexible and adapt quickly to the changing needs of the organization
Link:
https://en.jobs.sanofi.com/job/cambridge/remote-statistical-project-leader-associate-director/20873/27860234464
Statistical Project Leader (Associate Director)
Sanofi
Provide leadership, guidance, and strategic input as the lead statistician on one or more project team(s), accountable for all statistical aspects of project(s). Act as key statistical consultant within company. Work with Group head about project staffing and responsible for resource planning and allocation within project B&P team.
Basic Qualifications:
PhD/MS in statistics or related discipline with more than 8 years of pharmaceutical experience.
Excellent knowledge of pharmaceutical clinical development, together with Late Phase experience.
Demonstrated very strong project management, interpersonal and communication skills.
Excellent knowledge and good understanding of advanced statistical concepts and techniques.
Proven successful experience in clinical development or post-marketing activities such as submissions, interactions with regulatory agencies or other external stakeholders.
Broad Experience in the relevant therapeutic area desired.
Ability to represent Sanofi in major cross-company activities such a consortiums or professional associations.
Link:
https://en.jobs.sanofi.com/job/bridgewater/statistical-project-leader-associate-director/20873/27950614352
Statistical Programming Project Leader
Sanofi
Job Summary:
Lead one or more statistical programming project team(s) in the Rare Diseases and Rare Blood Disorder projects. Responsible for all programming activities at the project/indication level. In addition, contribute to the therapeutic area and department initiatives and task forces for innovation and process improvements.
Required Education/Experience:
Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
MS / BS with at least 5+ / 7+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry
Excellent technical skills in statistical programming, with advanced knowledge in SAS and other statistical computing software (R, R-Shiny)
Ability to perform, coordinate and oversee the preparation, execution, reporting and documentation of all programming deliverables of a project, with minimal supervision
Knowledge on regulatory requirement evolution (SDTM, SDRG, ADRG, ADAM, XML format, etc.); thorough understanding of pharmaceutical clinical development (i.e., statistical concepts, techniques, and clinical trial principles) and ability to lead regulatory submissions
Ability to collaborate with external partners (CROs, Partners, etc.) and manage outsourced activities
Excellent verbal and written communication skills in an English global environment; ability to have efficient exchanges with partners, service providers, and colleagues across geographical locations
Strong skills that demonstrate initiative, motivation, and teamwork in global interdisciplinary teams
Ability and mindset to embrace change, innovate and continuously improve programming practice
Link:
https://en.jobs.sanofi.com/job/bridgewater/statistical-programming-project-leader/20873/21422313248
Study Statistician
Sanofi
At Sanofi, we have a shared commitment to bring innovation and rigor to our competitive program, from bench to bedside. Our global department invests in the development of all our team members, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives.
Position Overview
Assume responsibility for methodological and statistical aspects of one or several clinical studies, under close supervision of statistical project leader and/or team leader. Support one or several late phase studies or lead one or several standard studies or domains in non-onco early development. Act as a statistical consultant within the study team.
Required Education/Experience:
PhD in statistics or related discipline.
Basic knowledge of pharmaceutical clinical development
Good knowledge and good understanding of key statistical concepts and techniques
Able to work in departmental computing environment, do advanced statistical analyses using SAS and possibly other languages (R, …)
Demonstrated interpersonal and communication skills
Link:
https://en.jobs.sanofi.com/job/bridgewater/study-statistician/20873/27860234256
(REMOTE) Statistical Project Leader, Associate Director
Sanofi
At Sanofi, we have a shared commitment to bring innovation and rigor to medical affairs and post-marketing support. As Statistical Project Leader, you will be responsible for developing, coordinating, and performing all statistical work, strategic, scientific, and operational, in support of medical affairs and post-marketing for several projects in immuno-inflammation area.
You will be supported by a Biostatistics and Programming Department that invests in the development of all our team members, offering compelling career opportunities that value diversity of opinions and talents, to optimize overall success and have a meaningful impact on patients’ lives.
Link:
https://en.jobs.sanofi.com/job/bridgewater/remote-statistical-project-leader-associate-director/20873/27860234416
Statistical Programming Project Leader
Sanofi
Position Overview:
The incumbent is a programming project lead (PPL), responsible for all programming activities at the level of a project, i.e. all studies and submissions.
Key Responsibilities:
Provides and maintains project plan for all projects/studies including milestones, tasks, and coordination of programming activities.
Provides leadership and guidance to ensure high quality and timely statistical programming deliverables within a project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirements.
Ensures standardization and consistency of documents and programming deliverables across studies (clinical study reports, CSR) and for integrated analyses (ISS/ISE).
Provides technical guidance and leadership to metadata specifications and project/study specific data requirements.
Plans and leads regulatory submission activities.
Supervises the quality controls (QC) methods and processes for programming deliverables in both study and submission level activities.
Participates in clinical project meetings and provide input, whenever relevant.
Formal Education and Experience:
A candidate with a Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred.
A candidate with a Master degree and 5+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.
A candidate with Bachelor degree and 7+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.
Link:
https://en.jobs.sanofi.com/job/bridgewater/statistical-programming-project-leader/20873/26620447200
Statistical Programming Project Leader
Sanofi
Position Overview:
The incumbent is a programming project lead (PPL), responsible for all programming activities at the level of a project, i.e. all studies and submissions.
Key Responsibilities:
Provides and maintains project plan for all projects/studies including milestones, tasks, and coordination of programming activities.
Provides leadership and guidance to ensure high quality and timely statistical programming deliverables within a project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirements.
Ensures standardization and consistency of documents and programming deliverables across studies (clinical study reports, CSR) and for integrated analyses (ISS/ISE).
Provides technical guidance and leadership to metadata specifications and project/study specific data requirements.
Plans and leads regulatory submission activities.
Supervises the quality controls (QC) methods and processes for programming deliverables in both study and submission level activities.
Participates in clinical project meetings and provide input, whenever relevant.
Formal Education and Experience:
A candidate with a Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred.
A candidate with a Master degree and 5+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.
A candidate with Bachelor degree and 7+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.
Link:
https://en.jobs.sanofi.com/job/bridgewater/statistical-programming-project-leader/20873/26279454912
Sr. Data Standards Leader
Sanofi
ob Summary:
Leads large or complex or E2E standards process improvement or analysis and reporting standards projects in Data Standards and Operations (DSO) group. Accountable for the planning, execution, and delivery of these projects via cross-functional collaboration.
Major Responsibilities:
Leads large or complex or E2E analysis and reporting standards and process improvement projects, closely adhere to the mission and vision of DSO group, plan and execute activities for the responsible projects.
Leads global process/technical WGs within department or cross-functional, contributes to the identification and development of programming standards and templates to facilitate the creation of B&P deliverables, as well as work instructions and process improvement activities.
Provides project management and support to the evaluation of updates of standards and their impact to the study teams, to ensure smooth implementation and compliance to standards, SOPs, and regulatory requirements.
Serves as a B&P internal expert to provide sustained support on the change management of standards. Mentors, communicates, and trains on the use of department standards.
Collaborates effectively and extensively within B&P, cross-functionally (e.g., statisticians, ITS, Data Management, Clinical Information Governance, medical writing, etc.) and vendors; identifies and executes impactful partnerships.
Ensures timely communication via webinar, newsletter, Yammer on DSO related projects to the user community and to the management (i.e., at LT meetings)
Leads or contributes to influence in external standards working groups.
Link:
https://en.jobs.sanofi.com/job/bridgewater/sr-data-standards-leader/20873/28107372432
Study Lead Programmer
Sanofi
Overview
Plan and execute high quality and timely statistical programming deliverables within a late phase study in Rare Diseases and Rare Blood Disorder projects. In addition, contribute to the therapeutic area and department initiatives and task forces for innovation and process improvements.
Major Responsibilities:
Programming Study Lead (SP) of a late phase study / early phase project. With limited direction from programming project leader, plan and execute statistical programming activities for the responsible study.
Perform programming activities for all statistical deliverables within a study/project, e.g. SDTM, ADaM, Tables Listings and Figures (TLF) for Data Monitoring Committee Reports (DMC, if any), Interim Analysis (if any), Clinical Study Report, DSUR, Transparency (Eudract, CTGov, Lay Summary), Data Surveillance Report, Publications and any exploratory analyses
Perform quality control for statistical programming deliverables, propose to the PPL the validation plan and completes the associated documentation: Validation plan and quality control (QC) documentation
Review and provide feedbacks on study documents, such as protocol (statistical section), Case Report Form (CRF), Statistical Analysis Plan (SAP) and Table Listing and Figures (TLF) templates.
Write and provide the programming specifications for the Study Data Tabulation Model (SDTM) and Analysis Datasets Model (ADaM) for a study
Provide items required for an electronic submission (following regulatory requirements)
Ensure compliance to department SOP’s, standards, and guidelines
Collaborate with study statistician and PPL
Collaborate with data management team on data issues
Collaborate with external partners and support outsourcing oversight activities
Participate in working groups within the department
Support department initiatives and contributes to department standards and processes
Provide in timely manner the archiving of any programming documents in the CTP
Link:
https://en.jobs.sanofi.com/job/bridgewater/study-lead-programmer/20873/26620455440
Statistical Project Leader, Associate Director
Sanofi
Job Summary
Provide leadership and guidance as the lead statistician on one or more oncology late phase project team(s), accountable for all methodological and statistical aspects of project(s). Act as statistical consultant within company.
Major Duties and Responsibilities
Lead a project /one or several indications of a project in oncology late phase development.
With minimal direction from group head, direct statistical support and provide scientific leadership for responsible project. Accountable for statistical aspects of clinical development plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.
Mentor people working on the project. Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment. Ensure project team compliance with SOPs and departmental standards.
Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization through efficient and well-managed resource allocation and across projects or areas. Capacity to respond to unscheduled increase in project workload.
Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
Represent statistics in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards.
Link:
https://en.jobs.sanofi.com/job/cambridge/statistical-project-leader-associate-director/20873/27900552320
Senior Manager, Statistics
Takeda Pharmaceuticals
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, Statistics, in our Cambridge office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
OBJECTIVE:
The purpose of this position is to provide compound level / development phase statistical expertise and leadership by:
• Independently designing, analyzing and interpreting clinical or observational studies at a compound level for early phase or less complex programs.
• Providing strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions.
• Improving and using standards to maximize global data integratability, interpretability and compound level efficiency.
• Leveraging internal and external resources to achieve quality, timely and cost-effective compound level and submission deliverables.
• Independently representing Statistics function in interactions with regulatory authorities.
Link:
https://takeda.wd3.myworkdayjobs.com/External/job/Boston-MA/Senior-Manager--Statistics_R0056428
Senior Staff Biostatistician
illumina
Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. We are hiring a Sr. Staff Biostatistician to work on clinical validation and product development of companion diagnostics to enable precision medicine in oncology.
The successful candidate will be the subject matter expert in statistics and provide thought leadership in clinical study design, analysis, and reporting, for registrational studies for in vitro diagnostic (IVD) and companion diagnostic (CDx) assays in the US and internationally (including FDA PMA, 510(k), and equivalent EU approval).
For a complete job description and to apply for the position please click the following link:
https://illumina.wd1.myworkdayjobs.com/illumina-careers/job/US---Remote/Sr-Staff-Biostatistician-Oncology---Clinical--Remote-_32225-JOB
Link:
https://illumina.wd1.myworkdayjobs.com/illumina-careers/job/US---Remote/Sr-Staff-Biostatistician-Oncology---Clinical--Remote-_32225-JOB
Senior Biostatistician to Director
AbbVie
Statistical Innovation group in AbbVie is actively hiring! From fresh PhD level to experienced Director level. Looking for strong (Bayesian) adaptive design experts with strong publication records! I just hired a tenured associate professor! So academia is highly welcomed!
Link:
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