Fwd: משרה בחברת טבע

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Tal Galili

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Jul 12, 2018, 3:49:44 PM7/12/18
to isa-jobs
אנו מחפשים Associate Dir Statistics שיתמוך במחלקת ניסויים קליניים, אם מהפן של תכנון תכניות קליניות, בניית אסטרטגיות, פרוטוקולים של ניסויים, רגולציה, תמיכה בהגשות וליווי E2E סטטיסטי במחלקה.

כמו כן, המחלקה יושבת שרובה בארה"ב והכפיפות הינה ל- Dir Statistics

 

בנוסף, תיאור התפקיד באתר קריירה ולינק.

 

תודה רבה ויום נעים

 

The Associate Director, Statistics position is for a skilled statistician, with experience in clinical development. The applicant is expected to provide statistical leadership and strategy for a program and studies. Solid knowledge of statistical principles, methodology and software is required. The applicant must be a strong individual contributor, demonstrating creative and strategic thinking and knowledge of modern trial design.  Experience with regulatory interactions in the US and outside  is required. Excellent communication skills are required. This position will be located in Netanya, IL.

Key responsibilities

Strategic and scientific leadership to the clinical development, registration strategy, submission, and medical affairs across multiple diseases

Collaborating and consulting with stakeholders

Strategic and/or managerial responsibilities for Biostatistics across multiple programs

Effective partnership with R&D functions including clinical and regulatory to drive quantitative decision and enable successful programs

Interact with KOLs and represents Teva in external scientific, regulatory and industry forums

Ability to use of innovative trial designs and statistical methodology

Knowledge of the therapeutic area and its competitive landscape

Provides consultation on endpoints and sample size planning

Prepares, or oversees the preparation of, statistical sections of protocols

Writes, or oversees the writing of, statistical analysis plans

Provides statistical input for CRF design

Conducts, or oversees the conduct of, analyses to support study reports and publications

Involved in CRO selection for outsourced activities, and oversees the CRO work

Consults and mentors other statisticians on methodology and trial design

Develop and maintain departmental SOPs and ensure their compliance

Supports due diligence activities

 

Qualifications:

MA/MS/PhD in Statistics/Biostatistics (or related field) with a minimum of 10 years of related experience

Excellent oral and written communications skills

Expert in planning, analysis and reporting of clinical trials

Ability to work in a global organization

Ability to communicate with non-statisticians to interpret statistical findings

Experience working in an outsourcing model

Good organizational and problem-solving skills

Demonstrated technical qualities

Creative and strategic thinking

Ability to program using SAS, knowledge of R is beneficial

Knowledge of CDISC SDTM and ADaM

Knowledge of relevant regulatory guidelines

Experience with regulatory interactions in the US and outside

Demonstrated ability to deliver quality products with efficiency

Technical and scientific publications is beneficial

https://israel.careers.teva/requisition.html?id=5277

 

 

בברכה,

נופר דולברג

רכזת גיוס וסורסינג

039166102

cid:image001.png@01CB75BC.EA233B30

 


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