Teva Senior Manager Clinical Statistician 

United States, New Jersey 

2717726

The Senior Manager Clinical Statistician is a skilled statistician with training and experience in drug development and clinical research. You'll be expected to provide statistical support to clinical studies or programs within Teva Global R&D. The support includes, but not limited to, strategic planning, study designs, data analyses, and regulatory interactions. You'll be expected to have extensive knowledge about statistical principles and appropriate software and tools to perform his or her tasks. The Senior Manager Clinical Statistician should be a strong individual contributor and demonstrates leadership qualities with creative and strategic thinking. Must have excellent written and oral communication skills and demonstrate the ability to successfully working in a global environment.

• Primarily works at the Product/Program Level.
• Provide input for budget planning.
• Manage and Deliver assignments with quality and within timelines.
• Possible to have direct reports; Possible to oversee contingent workers and/or vendors; likely to provide training to others; Analyzes needs to manage resources.
• Responsible for statistical aspect of study designs and data analyses for clinical studies.
• Provides study design input and consultation for clinical endpoint assessments and sample size planning.
• Prepares, or oversees the preparation of statistical sections of clinical protocols in collaboration with key stakeholders, as deemed necessary.
• Writes, or oversees the writing of, statistical analysis plans.
• Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts, and other documents to support the marketing of Teva products.
• Leads the conduct of analyses and document preparation to support global regulatory submissions, including briefing packages, integrated analyses, and regulatory responses.
• Collaborates with outsourcing partners and oversees conduct of statistical aspects of outsourced studies, as appropriate.
• Proactively assesses and identifies processes that require improvement.
• Participates in department initiatives to further the effectiveness of global statistics.
• Implements innovative and cutting-edge clinical trial design, methodology and analysis.

Position Requirements:

• MS with a minimum of 4 years of related experience; PhD with a minimum of 2 years of related experience

Specialized or Technical Knowledge Licenses, Certifications needed:

• Provide strategic statistical support to clinical studies or programs with the guidance of senior level statisticians (i.e., Associate Director or higher) which includes, but is not limited to, clinical development plans, complex study designs, data analyses, and regulatory interactions. Independently provides study design input and consultation for study endpoint assessment and sample size planning. Needs to be able to implement innovative and cutting-edge clinical trial design, methodology and analysis.

Job-Specific Competencies:

• Contributes to strategy under moderate supervision.
• Tackles difficult problems; Identifies solutions and leads decisions to resolve.
• Influence communication toward common understanding and actionable results; Leads process development and improvement.
• Expert in the planning, analysis and reporting of clinical trials.
• Experience working in an outsourcing model (fully or functional outsourcing).
• Good organizational and problem-solving skills.
• Ability to program using SAS or JMP, knowledge of R is beneficial.
• Knowledge of relevant ICH, FDA and CHMP guidelines.
  

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
  

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