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Become A Biostatistics Director

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Working As A Biostatistics Director

  • Getting Information
  • Establishing and Maintaining Interpersonal Relationships
  • Making Decisions and Solving Problems
  • Organizing, Planning, and Prioritizing Work
  • Updating and Using Relevant Knowledge
  • Mostly Sitting

  • $120,160

    Average Salary

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

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How To Become A Biostatistics Director

Natural sciences managers usually advance to management positions after years of employment as scientists. Natural sciences managers typically have a bachelor’s degree, master’s degree, or Ph.D. in a scientific discipline or a related field, such as engineering. Some managers may find it helpful to have an advanced management degree—for example, a Professional Science Master’s (PSM) degree, a Master of Business Administration (MBA), or a Master of Public Administration (MPA).

Education

Natural sciences managers typically begin their careers as scientists; therefore, most have a bachelor’s degree, master’s degree, or Ph.D. in a scientific discipline or a closely related field, such as engineering. Scientific and technical knowledge is essential for managers because they must be able to understand the work of their subordinates and provide technical assistance when needed. 

Natural sciences managers who are interested in acquiring postsecondary education in management should be able to find master’s degree or Ph.D. programs in a natural science that incorporate business management courses. A relatively new type of degree, called the Professional Science Master’s (PSM), blends advanced training in a particular science field with business skills, such as communications and program management, and policy. Those interested in acquiring general management skills may pursue a Master of Business Administration (MBA) or a Master of Public Administration (MPA). Some natural sciences managers will have studied psychology or some other management-related field to enter this occupation.

Sciences managers must continually upgrade their knowledge because of the rapid growth of scientific developments.

Work Experience in a Related Occupation

Natural sciences managers usually advance to management positions after years of employment as scientists. While employed as scientists, they typically are given more responsibility and independence in their work as they gain experience. Eventually, they may lead research teams and have control over the direction and content of projects before being promoted to an administrative position.

Licenses, Certifications, and Registrations

Although certification is not typically required to become a natural sciences manager, many relevant certifications are available. These certifications range from those related to specific scientific areas of study or practice, such as laboratory animal management, to general management topics, such as project management, and are useful to natural sciences managers regardless of the organization being managed.

Important Qualities

Communication skills. Natural sciences managers must be able to communicate clearly to a variety of audiences, such as scientists, policymakers, and the public. Both written and oral communication are important.

Critical-thinking skills. Natural sciences managers must carefully evaluate the work of others. They must determine if their staff’s methods and results are based on sound science.

Interpersonal skills. Natural sciences managers lead research teams and therefore need to work well with others in order to reach common goals. Managers routinely deal with conflict, which they must be able to turn into positive outcomes for their organization.

Leadership skills. Natural sciences managers must be able to organize, direct, and motivate others. They need to identify the strengths and weaknesses of their workers and create an environment in which the workers can succeed.

Problem-solving skills. Natural sciences managers use scientific observation and analysis to find solutions to complex technical questions.

Time-management skills. Natural sciences managers must be able to do multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule.

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Biostatistics Director jobs

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Biostatistics Director Demographics

Gender

  • Male

    66.7%
  • Unknown

    19.0%
  • Female

    14.3%

Ethnicity

  • White

    59.3%
  • Asian

    32.1%
  • Hispanic or Latino

    6.6%
  • Black or African American

    1.1%
  • Unknown

    0.9%
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Top Skills for A Biostatistics Director

ClinicalTrialResultsSASDataManagementActivitiesCROPerformanceReviewsFda/EmeaStatisticalAnalysisPlansDsmbDepartmentBudgetBusinessDevelopmentGuidelinesDataSafetyRegulatorySubmissionsBiostatisticsDepartmentClinicalDevelopmentProgramsStatisticalActivitiesStatisticalSupportSdtmCdiscAdam

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Top Biostatistics Director Skills

  1. Clinical Trial Results
  2. SAS
  3. Data Management Activities
You can check out examples of real life uses of top skills on resumes here:
  • Authored, reviewed and provided statistical analyses for publications on clinical trial results.
  • Developed SAS programs for statistical analyses and generating data tables, figures and listings.
  • Directed all statistical and data management activities within the company.
  • Provided cross unit review of resources and work load leveling.
  • Provide statistical guidance to clinicians, write statistical section for study protocols and prepare statistical analysis plans.

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