What Does A Biostatistics Director Do At Astellas Pharma
* Participates in project teams for clinical development programs and/or lifecycle management of marketed products* Provides strategic statistical input to the project teams and is a major contributor to the clinical development plan (CDP).* Ensures CDP with statistical integrity and optimal study designs, and ensures that Data Science needs are reflected within the development plan and strategy across regions.* Provides statistical advice to clinical teams including design of studies and analyses requiring advanced statistical methodologies.* Recognizes and addresses issues which may impact the statistical integrity of the development program or for which statistical tools may add value.* Provides best in class data science support to Astellas drug development programs and leads the Data Science extended (project) team and deliverables teams.* Ensures quality and consistency of key data science deliverables across studies.* Ensures creation of, maintenance and adherence to indication specific standards with respect to key variables, definitions, statistical methods, data structures and presentation of results.* Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs.* Represents the company on statistical matters at meetings with regulatory authorities, key opinion leaders and similar experts / bodies* Reviews key project and study documents to ensure optimal statistical presentation and compliance.* These documents include, but are not limited to, clinical development plans (CDPs), protocols, analysis plans, study reports, submission documents and correspondence with health authorities.* For studies within assigned projects:* Provides all required statistical support and deliverables by supervising another statistician in that role, or as a member of study team him/herself.* Writes or reviews key study documents to ensure optimal statistical presentation and compliance.* These documents include, but are not limited to, protocols, analysis plans, tables, listings, and figure (TLF) specifications, study reports.* Ensures efficient planning, execution and reporting of clinical studies and statistical review of critical documents such as CRFs, Data Validation Plans, SDTM/ADaM data specifications, TLFs* Ensures statistical analyses performed in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines.* Provides (executive) top line reports of study results* When statistical support or SAS programming for studies or other deliverables within assigned projects are contracted out to a CRO:* Contributes to vendor selection.* Performs vendor oversight for assigned programs: Ensures CRO is provided with details, timelines and Astellas specifications and requirements and kept up to date in case of changes.* Monitors timelines, progress and specific issues, and takes action if necessary.* Ensures review of the outputs created by the CRO.* Other tasks and roles may include:* Major contributor to cross-departmental/departmental/sectional improvement initiatives, for example: write SOPs; select, validate and implement statistical software; generate standard output or analysis methods.* Member or leader of external industry or professional organizations.* Develops and maintain relations with leading academic institutions.* Perform vendor qualification / audits in collaboration with functional management* Investigates new statistical methodology and feeds back to department and project teams
What Does A Biostatistics Director Do At CSL Behring
* Lead full scope of Biostatistics contributions to the responsible areas. Coordinate with internal and external stakeholders through the Stage Gate process.* Partner with TA Head and other functional leads within the areas. Influence and contribute to clinical development plans (CDPs/TPPs).  Ensure full integration of statistical strategy and quantitative evaluation to clinical trials, regulatory submissions, and related documents.* Ensure sound statistical foundation underpinning program strategy within the responsible area. Be accountable for the quality of statistical strategy and analysis planning for clinical trials and regulatory submissions.Â* Represent Biostatistics in interactions with authorities, including FDA, EMA, PMDA, etc.* Provide statistical leadership dealing with concepts and complexity comfortably. Interact effectively with senior management and external KOL.* Coordinate priorities and monitor outsourcing operations within the responsible areas. Ensure timeliness and quality of deliverables by CRO.* Manage the Biostatistics team to achieve corporate and department goals. Provide technical statistical expertise, leadership and serve as a role model and mentor to staff. Mentor staff and cultivate professional growth.Â* Extend influence and leadership across functions. Identify and lead opportunities for infrastructure / process / scientific consulting improvement initiatives and related standards
What Does A Biostatistics Director Do At Sanofi Group
* Oversee statistical support to multiple project teams.* Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols.* Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project.* Statistically valid CDP involving one or more studies designed to lead to a key decision point or submission.* CDP, related protocols, and statistical analysis plans (SAP) consistent with overall project objectives.* CDPs have degree of optimality in terms of timing, use of resources, and probability of success.* Oversee execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries.* Review and approve key results memos and statistical conclusions.* Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package.* Ensure statistical representation at regulatory or other external meetings.* Completed data package relevant for submission or making key decisions.* Statistical deliverables consistently compliant, in timing and quality, with SOPs and departmental standards.* Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs (TLG).* Effect consistency of data collection and analysis across project or area.* Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects.* General compliance with Sanofi-aventis standard data models, e.g.* CIDSC.* Plan and track project activities, timelines, and resource use across projects.* Provide justification for planned resource needs.* Seek to optimize resource utilization and capacity.* Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation.* Ensure mentoring and development of staff.* Encourage personal development in the context of project work.* Learn and apply techniques to promote teamwork, quality, and motivation.* Manage conflict.* Productive work environment, individual growth, development of strong contributors.* Staff compliance with SOPs and departmental policies.* Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP.* Within area of control, update procedures or practices as needed to remain in compliance.* Procedures and practices meet industry standards and are consistent with internal SOP.* Serve as departmental representative on division or corporate-wide teams.* Advocate application of statistical thinking in decision-making.* Work effectively with leaders in other functional areas.* Effective corporate use of statistical thinking.* Efficient processes in clinical development and operations
What Does A Biostatistics Director Do At J&J Family of Companies
Monitors and manages the operations of the CVM statistics group
What Does A Biostatistics Director Do At Sanofi Group
* Understand existing studies, datasets and analyses well enough to inform team members and guide strategy for future analyses.* Harmonize statistical strategies and methods across departments Design, conduct, QC and report on agreed upon analyses.* This includes developing analysis specifications/plans, performing hands-on statistical programming and/or supervising external contractors doing such analysis and programming.* Analyses might be pre-planned or post-hoc, hypothesis testing or hypothesis generating, intended for dissemination or exploratory.* Present and/or explain findings to team members, internal managers, and/or external authors and experts.* Validate inferences.* Help craft listings and tables needed for abstracts, posters, slide decks, and manuscripts.* Be part of the JDAC team and support the brainstorming and prioritization of the required post-hoc analysis Provide consultation, input and guidance to cross-functional groups charged with development and submission of manuscripts, posters, slide presentations and abstracts.* Provide consultation, input and guidance to cross-functional groups charged with exploratory analyses and lifecycle management projects/studies.* Establish and maintain collegial and collaborative relationships with cross-functional group members, Medical Affairs leaders, alliance partners, colleagues in affiliate countries around the world, external medical writers, and external experts and authors.* Work with Publication Leads and team members to respond in a timely manner to journal editor and reviewer comments.* Review draft abstracts and manuscripts according to deadlines, and when appropriate, serve as an author.* In some cases, develop abstracts in close collaboration with external medical writers.* Serve as group's expert on methods sections.* As needed, support statistical analysis needs for dossier and/or response document submissions to HTA/payer bodies and independent therapeutic reviews (i.e. ICER) and analyses required by payers.* Depending on resource needs, assign tasks and supervise the work of external contract statisticians and programmers, as well as internal resources.* Review draft presentations and training materials, including posters and slide decks, according to deadlines.* Assist the Senior Director of Biostatistics when requested in any of his/her job responsibilities.* As needed, provide consultant-level support in developing Statistical Analysis Plans (SAPs)/stats sections of Phase 4 protocols (including performing sample size calculations), and supporting feasibility determinations for Phase 4 and HEOR studies, upon request.* Consult regarding primary and secondary endpoints as per medical strategy.* Upon request, review protocols and SAPs from Investigator-sponsored Studies.* As needed, perform all activities listed above, in collaboration with external co-development/commercialization alliance partner companies Maintain expertise in current statistical methods and standards relevant to pharma and biotech industry applications