Associate Director Biometrics
Date: Mar 20, 2021
Location: West Chester, Pennsylvania, US, 19380
Company: Teva Pharmaceuticals
Company Info
Job Description
The Associate Director, Statistics position is for a skilled statistician with training and significant experience in drug development and clinical research. He or she is expected to provide statistical leadership for overall program and individual study strategy within a therapeutic area. He or she needs to be knowledgeable about statistical principles and appropriate software and tools to perform his or her tasks. An Associate Director, Statistics must be a strong individual contributor, demonstrating leadership qualities, creative and strategic thinking and knowledge of cutting-edge clinical trial design and methodology for clinical studies. He or she must experience with regulatory submissions both in the US and outside of the US. He or she must have excellent written and oral communication skills.
Provides strategic input for study design and clinical development plan and consultation for clinical research protocols
Prepares, or oversees the preparation of, statistical sections of clinical protocols in collaboration with Clinical Research personnel.
Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts and other documents to support the marketing of CNS products
Ensures that data sets and their associated define files are prepared correctly and on time to support FDA submissions
Collaborates with outsourcing partners and oversees conduct of statistical aspects of outsourced studies, as appropriate
Qualifications
MA/MSc/PhD in Statistics/Biostatistics (or related field)
At least 7 years of related experience for PhD, or 10 years of related experience for MA/MSc
- Experience with regulatory submissions in the US
- Experience with regulatory submissions outside the US
- Ability to program using SAS, knowledge of R is beneficial
- Knowledge of CDISC SDTM and ADaM
Knowledge of relevant FDA and CHMP guidelines
Function
Sub Function
Reports To
Director Head Clinical Pharmacology
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Nearest Major Market: Philadelphia