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Become An Associate Director Of Biostatistics

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Working As An Associate Director Of Biostatistics

  • 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 An Associate Director Of Biostatistics Do At Regeneron Pharmaceuticals

* With minimal direction from departmental management, assume leadership role for providing statistical support to one or more project teams in the creation of a clinical development plan (CDP), study designs, and production of individual protocols.
* Work with other BDM members or consultants to develop effective statistical approaches applicable to project.
* Produce or review individual statistical analysis plan (SAP) and planned integrated summaries.
* Interact with the clinical / regulatory functions to define study endpoints and perform relevant sample size calculations.
* Learn key clinical and regulatory considerations, ensure that planned statistical methods are applicable, and communicate important statistical considerations to clients.
* Provide guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed to produce planned TFL.
* Assume responsibility for accuracy of derived variables.
* Effect consistency of data collection and analysis within project.
* Oversee production of the statistical analyses according to SAP.
* Oversee preparation of the statistical methods and results sections for CSR and overall summaries.
* Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package.
* Serve as company statistical representative at regulatory or external meetings.
* Plan and track project activities, timelines, and resource use.
* Provide justification for planned resource needs.
* Seek to optimize resource utilization.
* Provide technical direction and mentoring to staff.
* Maintain awareness of industry standards and regulatory requirements and communicate within team.
* Encourage personal development in the context of project work.
* Learn and apply techniques to promote teamwork, quality, and motivation.
* Active research interest in area related to clinical trial.
* Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group.
* Participates in Regeneron task forces and cross-functional operational excellence initiatives

What Does An Associate Director Of Biostatistics Do At Sanofi Group

* Serve as Epi/Biostat lead for the MPS I Registry
* Lead the development of post marketing commitment (PMC) linked regulatory analysis/reports based on the Registry data
* Lead the development of responses to Data Analysis Requests (DAR) received from Registry investigators, regulators, reimbursement authorities, and internal stakeholders for the MPS I Registry
* Work closely with theregistryteamsandexternaldiseaseexperts to leadthedesignandconductofinnovativeepidemiologicalandbiostatisticalanalyses,ofboththenaturalhistoryofthediseasesaswellaslong-termtreatmentoutcomes
* Provideepidemiologicadviceanddirectionforthedesignofnewregistry sub-studies, aswellastheongoingconductoftheregistries
* Presentwork-in-progressandfinalanalyses via teleconference/WebExmeetingsorin-personmeetings to Registry advisors and internalstakeholders
* Interact directly with Registry investigators to develophypotheses,analyses,andreports to addresskey medical questions to improve patient care and therapeutic outcomes
* DevelopanalysisplansforimplementationbyStatisticalProgrammingteam
* Collaborate with medical communicationsteam to prepareconferenceabstractsandmanuscriptsforpublication in peer-reviewed scientific journals
* Provide internal and external training on the concepts and methods of epidemiology asapplied to rarediseasesandtheirtreatment
* Domestic and international travel required to participate in Registry Board of Advisors meetings and other scientific conferences (~10% of time

What Does An Associate Director Of Biostatistics Do At Bristol Myers Squibb

* Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate
* Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product
* Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use.
* Develops trial designs that address study objectives that will support regulatory approval and market access
* Translates scientific questions into statistical terms and statistical concepts into layman terms
* Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information
* Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis
* Communicates effectively with clinical and regulatory partners and external opinion leaders
* Builds the external reputation of BMS R&D via external interactions through collaborations with alliance partners, academic and government research organizations and through conference participation
* Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents
* Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted
* Compliant with BMS processes and SOPs, global and project standards, and responsible for quality of deliverables
* Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information
* Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles
* Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team
* Drives alignment at team (IPT) level, and escalates lack of team alignment to the GBS Lead for resolution
* Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions
* Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project
* Keeps up-to-date with state-of-the art applied statistical methodologyImpact:The Biostatistician is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level.
* These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success.
* This role has significant stakeholder management responsibility with business partners on their team.
* The biostatistician has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data.
* This person may interact with external vendors, key opinion leaders and regulatory agencies

What Does An Associate Director Of Biostatistics Do At Sanofi Group

* The
* Associate Director of Biostatistics (Immunology)** will be a key member of several teams responsible for the development and conduct of statistical analyses contributing to the submission of publications and presentations arising from Genzyme-sponsored clinical studies, including Phase 3 and 4 studies and exploratory analyses.
* This position supports Global Medical Affairs and in-market products (Sarilumab and Dupilumab) and the analyses will be mostly post-hoc and oriented toward the needs of Immunology disease area-related conferences, health care provider and payer audiences.
* The AD Biostatistics will provide input to cross-functional groups led by Medical Affairs who brainstorm, select, and prioritize new post-hoc analyses to meet specific strategic goals, and to groups who develop the abstracts and manuscripts.
* The incumbent will furthermore be accountable for performing, QC'ing and fine-tuning the chosen analyses, plus explaining and interpreting findings for internal colleagues, management, and external authors — this is a hands-on role.
* Statistical approaches and methods will require innovative and customized approaches.
* The AD, Biostatistics would also "own" the tracking documents and file archives for analysis plans, programming code, output, and associated reports.
* They will collaborate closely with internal statistics leaders and cross functional teams, as well as with our alliance partner companies, as relevant, and when necessary, oversee the work of external biostatistics and programming contractors.
* This is an exciting opportunity to be part of an active, high profile, high-impact Medical Affairs Department, to perform interesting and complex statistical analyses in support of key product launches.
* Major Duties and Responsibilities:
* 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.
* 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 An Associate Director Of Biostatistics

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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Associate Director Of Biostatistics jobs

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Real Associate Director Of Biostatistics Salaries

Job Title Company Location Start Date Salary
Associate Director, Biostatistics Millennium Pharmaceuticals, Inc. Cambridge, MA Jan 14, 2011 $155,400
Associate Director, Biostatistics Novartis Pharmaceuticals Corporation East Hanover, NJ Nov 09, 2016 $150,347
Associate Director, Biostatistics Novartis Pharmaceuticals Corporation East Hanover, NJ Jan 10, 2016 $146,117
Associate Director, Biostatistics Novartis Pharmaceuticals Corporation East Hanover, NJ Jun 22, 2015 $142,100
Associate Director, Biostatistics Novartis Pharmaceuticals Corporation East Hanover, NJ Sep 12, 2015 $140,862
Associate Director, Biostatistics Eisai Inc. Woodcliff Lake, NJ Dec 14, 2009 $140,000
Senior Associate Director, Biostatistics Novartis Pharmaceuticals Corporation East Hanover, NJ Oct 21, 2014 $138,099
Associate Director (Technical) Biostatistics Eisai Inc. Woodcliff Lake, NJ Jun 01, 2011 $135,000
Associate Director, Biostatistics Novartis Pharmaceuticals Corporation East Hanover, NJ Sep 29, 2014 $134,008

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Top Skills for An Associate Director Of Biostatistics

StatisticalAnalysisPlansSASCRODataManagementStrategyRegulatoryQCIIIStudyProtocolsEfficacy/PharmacodynamicDataClinicalDataTranscriptionistsFDACRFDrugDevelopmentCorporateStandardsStatisticalSoftwareDataAnalysesSectionsStatisticalGuidanceStatisticalActivitiesEDCDunnett

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Top Associate Director Of Biostatistics Skills

  1. Statistical Analysis Plans
  2. SAS
  3. CRO
You can check out examples of real life uses of top skills on resumes here:
  • Used statistical procedures in programming using SAS statistical software.
  • Work cooperatively with other senior staff in defining and implementing Biostatistics operating procedures and policies and directing process uniformity across locations.
  • Served as the primary RDQC team member for large and complex studies.
  • Review study protocols, consult on correct statistical analysis for pre-initiation meetings.
  • Follow protocols according to GLPs, SOPs, and FDA regulations.

Top Associate Director Of Biostatistics Employers