Senior Statistician/Manager

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.Senior StatisticianImplement and execute methodological and statistical aspects of clinical studies under the supervision of the Therapeutic Area Head / Deputy (TAH / TAD) or project lead statistician.Duties and Responsibilities
Under direct supervision and guidance of senior departmental staff, provide support to a clinical trial team (CTT) on all relevant statistical matters. As member of CTT, ensure the clinical study is conducted in a manner that supports planned statistical analysis.
Under supervision and guidance of senior departmental staff, participate in preparation of study protocol and amendments. Review case report form (CRF) and provide comments and feedback.
Under supervision and guidance of senior departmental staff, develop statistical analysis plan (SAP).
Provide programming team with definitions and documentation for derived variables needed to produce planned TLG. Develop data and programming specifications jointly with programmers.
Perform statistical analysis according to the SAP, validate analysis programs, review TLG, prepare statistical methods and results sections for the clinical study report (CSR), and work with the CTT to move the CSR through review / approval process.
Perform statistical activities supporting clinical trial randomization, e.g., working with study managers, clinical drug supply liaison, specification of randomization schemes, and completion of request form.
Participate in technology development teams or scientific working groups. Participate in training on departmental processes, SOPs, guidelines, and policies.Major Challenges/Problems
Knowledge of industry is developed through training, experience, and interaction with supervisor.
Gaining expertise in clinical trials and pharmaceutical development.
Gaining knowledge in statistical methods applicable to clinical trials.
Developing capability in departmental computing environment.
Working with and influencing multidisciplinary team.
Learning company policies, procedures, and technical processes.
Hands-on experience with data and production of analyses appropriate for regulatory submission.Decision Making Authority
Provides guidance and clarification to CTT and programming team regarding details of SAP.
Works with project leader to identify limits of authority.
For key issues, may recommend positions to project leader for confirmation.
Responsible for identification of important issues requiring functional position or decision from project leader.Key Internal/External Relationships
Works closely with direct supervisor.
Develops understanding of functional responsibilities held by staff in other disciplines within company (clinical data management, regulatory, clinical, clinical documentation, and other groups).
Develops positive relationship with programming team.
Works with other members of department on research projects or working teams.ManagerImplement and execute methodological and statistical aspects of clinical studies with direction from Therapeutic Area Head / Deputy (TAH / TAD) or project lead statistician. Provide leadership and guidance on statistical matters to interdepartmental clinical / regulatory teams.Duties and Responsibilities
With periodic supervision and guidance from senior departmental staff, provide support and leadership to a clinical trial team (CTT) on all relevant statistical matters. Act as liaison to CTT, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis.
With some supervision and guidance from senior departmental staff, design clinical study and help produce protocol or amendments. Perform relevant sample size calculations. Develop statistical analysis plan (SAP).
Work with programming team to provide definitions, documentation, and review of derived variables needed to produce planned TLG.
Perform statistical analysis defined in SAP, prepare statistical methods and results sections for the clinical study report (CSR), and work with the CTT to move the CSR through review and approval process. Provide statistical insight into interpretation and discussion of study results.
Produce / coordinate production of statistical summaries, analyses, annual reports (INDAR), and related materials for submission to regulatory authorities or independent monitoring committees.
Provide assistance to project statistician or TAH/TAD in project activity and timeline tracking, resource planning, and preparation of scientific reports or position papers.
Provide technical guidance and mentoring to junior staff. Actively participate on technology development teams or scientific working groups.Major Challenges/Problems
Improving expertise in industry is accomplished through training and interactions with key persons in the company or external experts.
Developing in-depth statistical or methodological expertise in one or more areas applicable to clinical trials.
Gaining knowledge of regulatory concepts and becoming familiar with regulatory guidelines.
Increasing knowledge in one or more therapeutic areas.
Developing communication and interpersonal skills necessary to be an effective member of project teams.
Development of time-management and organizational skills.Decision Making Authority
Works within study team to define priorities and order of tasks to be accomplished.
May assume responsibility for certain technical aspects, such as validation of sample size calculations, plans for quality control of statistical analyses, or review of algorithms used in analysis data sets.
Responsible to alert project leader or TAH / TAD in case of unexpected results or changes in study conduct.
Responsible for assessing adequacy of data supporting key results in terms of sensitivity to missing data, presence of outliers, or departures from expected statistical model.Key Internal/External Relationships
Works with supervisor and other members of management team within department.
Develops working relationship with physicians or scientific clients.
Actively partners on projects with staff from other disciplines within company.
May participate on team interacting with external contractor / consultant.
REQUIREMENTS
Senior StatisticianKnowledge and Skills
Understanding of statistical concepts and techniques, such as inference, analysis of variance, linear models, regression, survival analysis, non-parametric analysis, estimation, hypothesis testing, and statistical modeling.
Familiarity with clinical trial concepts, such as randomization, hypothesis testing, estimation of treatment effects, sample size calculation, etc.
Ability to program basic data presentations (e.g. with SAS procedures MEANS, FREQ, UNIVARIATE, PLOT /GPLOT and the DATA step) and common statistical analyses (e.g. with SAS procedures GLM, MIXED, and LIFETEST).
Competency in written and spoken English.Formal Education/Experience
PH.D. in statistics or related discipline, or MS with 2+ years of experience.Knowledge and Skills Desirable but not Essential
Training / consulting skills.
Expertise in one or more statistical areas.
Statistical computing.
Ongoing research activities.
Skills in non-English language.ManagerKnowledge and Skills
Knowledge of advanced clinical trial design concepts, such as non-inferiority, adaptive methods, type-I error protection, dynamic randomization, and sample size estimation in complex settings.
Knowledge of advanced statistical methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, sequential methods, and strategies for handling missing data.
Able to work in departmental computing environment, do advanced statistical analyses, program tables and graphs, and perform data transformations. In SAS, for example, ability to use procedures such as REPORT, GPLOT, REG, PHREG, LIFETEST, MIXED, specialized MACROs, and the DATA step.
Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines).
Ability to clearly describe advanced statistical techniques and interpret results.
With some supervision, ability to formulate statistical objectives, design, and analyses for complex clinical projects.
Ability to meet timelines for deliverables such as key results and final analyses.
Good communication and negotiation skills.Formal Education
PH.D. (MS) in statistics or related discipline with 3+ (5+) years of experience.Knowledge and Skills Desirable but not Essential
Ability to write, review, and critically assess research reports / publications.
Statistical computing.
Ongoing research activities.
Experience in interaction with regulatory bodies and NDA submissions.