J’ai plusieurs postes de Biostatisticien(ne)s /Statisticien(ne)s à combler pour des compagnies pharmaceutiques aux Etats-Unis.

Veuillez trouvez ci-dessous un résumé de la description de tâches de chaque poste.

Si vous avez de l'expérience, êtes passionné(e) et êtes à la recherche d'un nouveau défi, je vous invite à me faire parvenir votre cv à l'adresse suivante:

86620 Statistician (with SAS R experience)
Location: IL

JOB DESCRIPTION:

Overview:
Company needs someone with strong computing skills (strong in R and preferably also in SAS, plus solid experience in Unix, JAVA, HTML, Perl, etc.), along with strong statistical training, and formal masters or Ph.D. degree in statistics.

Formal Job Description:
- Statistician in the Exploratory Statistics team in site.
- Educational Qualifications: Masters or Ph.D. in statistics, with coursework/experience in biochemistry

Primary Function:
- Provide statistical consulting and computing support for projects in areas such as drug discovery and pre-clinical and biomarker research (genomics, imaging, etc.), animal studies, in-vitro screening, clinical assays, etc.

Qualifications:
- At least two, but preferably five years of related experience with demonstrated skills/accomplishments as a statistician.
- Applications are also welcome from recent Ph.D. graduates that have done research on some of the topics noted above, with training and practical experience during school work.
- Expertise in statistical methodologies such as nonlinear regression, mixed effects models, multivariate analysis, predictive modeling, machine learning methods, etc., required.
- Strong school work (e.g., dissertation topic) and/or relevant academic/industry experience on topics related to drug discovery, genomics and other applications mentioned above.
- Strong computing skills in R is REQUIRED.
- Familiarity in web-based tool development, JAVA, Perl, Visual Basic, etc. and background in bioinformatics, biochemistry, and related subjects are also preferred.
- Also, please note that excellent verbal and written communication skills are required.

86309 Statistician III
Location: NJ

Statistician working on trial planning and analysis activities with review. Assists project statistician in preparing development programs for new drug indications.

1. Provides/lead primary statistical input for clinical study design.
2. Provides/lead analysis planning for clinical studies.
3. Provides/lead statistical input to clinical study reports.
4. Assists in clinical development planning for new drug indications.
5. Provides statistical support to other disciplines related to clinical statistics.
6. Ensures compliance with department SOPs and regulatory guidance.

Masters degree in Statistics or related field +2 years experience or PhD in Statistics or related field.

Basic knowledge of SAS programming and at least some other significant statistical software (e.g., S-Plus, PASS 2000). Demonstrated written and oral communication skills. Ability to work independently.

86927 Sr. Biostatistician
Location: NJ

REQUIRED:
Min of 5 years of solid stat experience and University degree (MSc, PhD) in Statistics, Mathematical Statistics or Biostatistics, or equivalent experience.
•Comprehensive knowledge of Clinical Drug Development processes and ability to and ensure compliance with regulatory authorities, quality and technical standards.
•5+ years of statistical experience with Global pharmaceutical companies, Clinical Research Organizations, or Business Process Outsourcing companies.
•Computer programming aptitude
•Good knowledge of spoken and written English.

Job Description:
Contract-to-perm opening for 2 Senior Biostatisticians with a MIN of 5 yrs exp in the industry.

Business and Functional Knowledge:
•Comprehensive knowledge of clinical and pharmaceutical drug development process and associated Good Clinical Practice (GCP).
•Awareness of regulatory requirements e.g. Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines.
•Multi-phase experience in Clinical research (phase 1, phase 2, phase 3, phase 4) in a variety of study complexities.
•Experience of different Therapeutic Areas (TAs).

Min of 5 years of solid stat experience and University degree (MSc, PhD) in Statistics, Mathematical Statistics or Biostatistics, or equivalent experience.
•Comprehensive knowledge of Clinical Drug Development processes and ability to and ensure compliance with regulatory authorities, quality and technical standards.
•5+ years of statistical experience with Global pharmaceutical companies, Clinical Research Organizations, or Business Process Outsourcing companies.
•Computer programming aptitude
•Good knowledge of spoken and written English.
•Good communication and presentation skills
•Demonstrated ability to work collaboratively in a team environment as well as independently.
•Demonstrated ability to manage own priorities and goals.

86756 Senior Statistician
Location: NJ

Job Description:
MS/PhD degree in statistics/biostatistics, with at least four years of experience working with/analyzing Phase II/III clinical data (in pharmaceutical or CRO), strong oncology experience preferred - good knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, summarization of data and presentation practices - hands on experience of survival analyses and categorical data analysis - proficiency in SAS, strong oncology programming experience preferred - preferred experience in NDA/BLA submissions - good knowledge of CDISC SDTM and ADaM - ability to work independently, toward the primary responsibility of preparing and validating analyses and preparing supporting documentation - good oral and written communication skills, - Candidate may work on-site or off-site but on-site visits will be required; frequency to be determined by hiring manager; on-site training required. This position requires hands-on programming, estimated to be at least 50%.

86529 Project Manager Statistician
Location: NJ

Job Description:
Key Accountabilities (Management) for PM.

1.
- Ensure adherence to company’s and Client SOPs
- Coordinate and communicate with Client Heads about resource requirements.
- Communicate with Client for MSA / SOW updates
- Participate in defining strategies for new processes and technology at either regional or global level
- Provide operational input into proposals and scope of work. Provide input to costing algorithms
- Provide guidance and supervision to the direct reports
- Ensure appropriate distribution of work among direct reports
- Ensure completion of training plan for all direct reports
- Security and Risk Managements
- Responsible for resource deployment, leadership, supervision and management oversight for DMC
- Clarify, manage and successfully implement customer expectations, resolving conflicts whilst pursuing win-win scenarios
- Effectively manage resource while ensuring delivery of full scope of data management work across the program, on time and within budget
- Supervision of resources across function and coordination of workload and responsibility
- Define and prioritize resource requirements and manage resource assignments across projects
- Monitor and manage utilization and productivity of unit.
- Regularly set goals and evaluate and document performance for direct reports
- Define recruiting strategies and staffing needs based on work load
- Monitor quality and efficiency across functions to identify trends and opportunities for improvements. Ensure sharing of learning across geographies
- Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work
- Responsible for resource deployment, leadership, supervision and management oversight for DMC
- Manage relationships with customer at both the operations level and with functional peers
- Lead discussions of project requirements and planning
- Actively assess and help manage project realization
- Ensure project milestones are met according to agreed upon timelines with high quality
- Coordinate and work closely with offshore Group leads

85629 Sr Statistician
Location: PA


Job Description:
• M.S. in Biostatistics or closely related field is required.
• Ph.D. in Biostatistics or closely related field is strongly preferred.
• 7+ years of relevant pharmaceutical development experience.

Provides input into development of the CDP and individual study design. Provides specification and reviews draft randomization schedules. Reviews and approves the SAP. Provides the statistical analyses. Reviews statistical outputs. Reviews the statistical methodology sections(s) of study reports for study and integrated summary reports.

Follows all relevant SOPs and working practices. Contributes to the establishment and maintenance of common formats and templates for key Biometrics documentation (eg statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings). Contributes to the design of standards for SAPs.

Supports Global Medical Affairs through consultation and review of abstracts, manuscripts and posters.

Communicates and interacts with the staff from various departments of the company and from CRO partners, consultants and academics concerning proper statistical methods. Provides strategic and tactical input in the contracting with Global Biometrics preferred providers.

• Strong background and working knowledge of statistical methods that apply to all phases of clinical trials. Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices.
• Must have a working knowledge of all appropriate relevant regulatory guidances (e.g. ICH, FDA and EMEA).
• Strong attention to detail and accuracy.
• Ability to read, analyze and interpret complex technical documents.
• Ability to communicate complex issues in oral and written form.
• Ability to establish priorities and meet deadlines.
• Must be able to work in a fast paced environment with demonstrated ability to prioritize multiple competing tasks and demands.
• Ability to work independently, take initiative and complete tasks to deadlines with quality.
• Demonstrated ability to work in a team environment.

Ability to communicate effectively upwards, downwards, and laterally throughout the organization Ability to determine appropriate designs and analyses for clinical trials.
Ability to respond to regulator’s inquiries for products undergoing registration and approved products.
Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed

85383 Biostatistician
Location: NC

Basic Purpose and Objective: Perform management functions relating to the administrative and scientific activities of specific project work and team members. Oversee statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians. Function as Biostatistics Project Leader for multiple protocols, projects, or NDA projects, including coordinating with other PPD divisions and interacting with the client and regulatory agencies.

II. Position Scope:
This position contributes directly to the company's revenue by performing statistical analysis on clinical trials. The quality of this analysis, as well as study design issues, is important in meeting client objectives.

Education and Experience:
-MS/MA degree in statistics, biostatistics, mathematics or related field and a minimum of four years experience required -Minimum of 2 years experience with PhD;. or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities Knowledge, Skills and Abilities:

• Strong SAS programming skills.
• Ability to direct and promote teamwork in a multi-disciplinary team setting.
• Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments.
• Evidence of strong management skills, as shown through management of multiple projects and/or staff members.
• Demonstrated initiative and motivation.
• Excellent written and verbal communications skills.
• Good organizational skills with the ability to adapt and adjust to changing priorities.
• Positive attitude and the ability to work well with others.

IV. Hiring Preferences: (Additional education/training, experience and knowledge, skills and abilities that are preferred but not required.)

Education and Experience:
• PhD degree is desirable.

Knowledge, Skills and Abilities:
• Two years of clinical trials experience preferred.

86258 Statistician
Location: MA

Candidate needs to have at least 2 years’ pharma stat exp with PhD or more with MS.
PhD preferred with 2+ yrs Stat, or MS with 5+ years, SAS experience, QC, Stat. analysis with scientific graphing and data manipulation, Stat support for Phase III trial development and filing activities. Oncology a big PLUS, not mandatory.

For this position, do NOT submit directors and high-level managerial candidates. NOT a lead position, but wants those who have ambitions of becoming a lead. Must be open to labor-intensive QC work, with possibility of advancement later. Some studies have over 16 protocols - workload exploded after Takeda merger. Position is in Oncology – high profile area.

86257 Statistician (Preclinical)
Location: MA

Ph.D. in Biostatistics or Statistics
• Knowledge and experiences in multivariate analysis, survival analysis, data mining, GLM, mixed effect model.
• Solid understanding of DoE
• Excellent consultation skills • Good communication and interpersonal skills
• Work effectively in a cross-functional team
• Work effectively under pressure and timeline
• Creative thinker with the ability to execute
• Willing to learn biology and a team player
• Strong computational skills in R, S-plus and SAS

86253 Statistician (Phase I/II and Health Economics / Outcomes Research)
Location: MA

MS or PhD in Statistical related discipline, with preferences towards Biostatistics, 2-5 years’ pharma with exp in SAS, statistical analysis, scientific graphing and data manipulation, some knowledge of NDA’s/BLA’s/IND’s & eCTD submissions. Position could convert to perm for the right person.

Position is providing statistical support for Phase I/II and Health Economics / Outcomes Research focusing mainly on analysis planning, developing specs for derived datasets, TFL shell developments, ad hoc data analysis, QC and communication with other functions.

86255 Statistician
Location: MA

• Ph.D. in Biostatistics or Statistics
• Must have extensive knowledge in assay development and validation & familiar with biology jargons.
• Knowledge and experiences in multivariate analysis, survival analysis, data mining, GLM, mixed effect model.
• Solid understanding of DoE
• Work effectively in a cross-functional team
• Willing to learn biology and a team player
• Strong computational skills in R, S-plus and SAS
• Excellent consultation skills

Position is assisting sr. biostatisticians in conducting design and analysis of studies in clinical biomarkers, in vitro assays, in vivo assays and providing statistical consultation.

86316 Statistician
Location: MD

REQUIRED: Candidates should have M.S. in statistics, biostatistics or related field and 1-3 years of SAS experience. A working knowledge of the UNIX/Windows environment, familiarity with SAS procedures for statistics, graphics, SQL, and macro languages and other analysis/graphics packages would be helpful. Experience in medical research with several years serving as a Study Manager is desirable. Individual should be ambitious and versatile with skills in preparing oral and written presentations

Job Description:
MS statisticians will be involved in the analysis and maintenance of large data bases using SAS and S-Plus. The study manager will work with the study Principal Investigator and clinical site staff to develop Protocols, Manuals, and manage the day-to-day operations of running a data/statistical coordinating center.

86457 Statistician
Location: WA

Client specific requirements:
MS in Statistics, minimum one year of experience, oncology experience preferred.

Provide statistical, clinical trial methodological, and regulatory input to study teams (e.g.. trial design, sample size estimation, randomization, statistical methods for protocols, query checks for clinical trial data). Produce detailed statistical analysis plans for clinical trials as well as for integrated summaries of efficacy and safety. Responsible for the analysis of clinical trial data, provide statistical input into the reporting of clinical trial results, and clearly communicate statistical results and concepts to non-statisticians. Provide input into statistical and data management processes. Participate in interactions with regulatory agencies as required.

MS Statistics/Biostatistics with at least 1 year of related experience Broad experience in clinical statistics, excellent written and oral communication skills. Strong ability to handle multiple projects simultaneously. Oncology experience is preferred.

Principal or Sr. Biostatistician
Location: 100% Home-based
Openings: Multiple openings
(Therapeutic areas: Oncology; Infectious Disease; CNS; Autoimmune)

RESPONSIBILITIES:
- Responsible for statistical methodology and statistical analysis plans for clinical studies as a member of the biostatistics team.
- Ensures that activities and processes performed are conducted according to company and sponsor requirements.
- This position works closely with the biostatistics and data management departments on various clinical projects.
- Act as lead Statistician on complex trials and across multiple studies.
- Act as a lead representative of the biostatistics department on project teams. Attend project team meetings as necessary.
- Meet with sponsors as requested during protocol development to ensure adequacy of proposed study designs with respect to statistical feasibility.
- Write statistical methodology sections of individual protocols. Write formal Statistical Analysis Plans to be carried out in the analysis of clinical studies.
- Perform statistical analyses of data and interpret results to ensure validity of conclusions. Meet with sponsor as requested throughout trial to discuss progress of clinical studies.
- Interact with data management personnel as necessary to ensure that datasets are in usable format; perform statistical diagnostics prior to database locking.
- Interact with SAS Programmers to ensure that appropriate programs are being developed for current clinical studies.
- Perform statistical quality assurance review and program validation for each project.
- Interact with medical writers in production of statistical and integrated clinical/statistical reports and other documents containing statistical information. Review statistical sections of draft documents.
- Interact with other departments, such as clinical operations and project management, to ensure a high level of client satisfaction through successful execution of projects.

QUALIFICATIONS:
- Graduate degree in Statistics, Biostatistics, or equivalent.
- Minimum 3years, preferably 5+, years experience performing clinical trial statistics.
- Excellent written and verbal English language skills.
- Understanding of regulatory (e.g., FDA, ICH) requirements.
- Ability to review and understand data from multiple sources.
- Ability to understand responsibilities of other functional areas (data management, medical writing, statistical programming, clinical) and work with their representatives.

Kodoré Camara
Senior BioStatistician

Camarako@lilly.com