Senior Manager Clinical Statistician at Teva Pharmaceutical Industries
Parsippany, NJ 07054
About the Job
Who we areTogether, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives
It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds
Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List
Today, at least 200 million people around the world take one of our medicines every single day
An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityThe 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
How you’ll spend your dayPrimarily 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.Your experience and qualificationsPosition Requirements:MS with a minimum of 4 years of related experience; PhD with a minimum of 2 years of related experienceSpecialized 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.Enjoy a more rewarding choiceWe 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.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 CommitmentTeva 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.Important notice to Employment Agencies - Please Read CarefullyTeva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place
Where agency agreements are in place, introductions are position specific
Please, no phone calls or emails.
It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds
Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List
Today, at least 200 million people around the world take one of our medicines every single day
An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityThe 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
How you’ll spend your dayPrimarily 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.Your experience and qualificationsPosition Requirements:MS with a minimum of 4 years of related experience; PhD with a minimum of 2 years of related experienceSpecialized 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.Enjoy a more rewarding choiceWe 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.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 CommitmentTeva 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.Important notice to Employment Agencies - Please Read CarefullyTeva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place
Where agency agreements are in place, introductions are position specific
Please, no phone calls or emails.
