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Sponsor Address

Bridgewater NJ, North NJ

Position Title

Director of Statistics

Number of Positions

1

Why is the position open?

Current Expansion

Sourcing Preferences

Independent.  Must come from the industry, Pharma development

Knock Out Factors

 Lack of PhD Lack References Must be available to work in NJ

Personality Desired

Team leader, Professional

Background of the last 2 Hired

no data

How long Open

Immediate

Employee needed by

Immediate

Number of Interviews

3 sets of interviews

Who Else Interviews

Senior Management

Salary

$175,000

Bonus

20%

First Year Income

$210k +

Benefits

Full complement executive package

Vacation Time

4 weeks

Who does the person report to

Top tier management, Matrix environment

Position Leads To

More senior positions

Position Selling Information

This is an opportunity for a proven professional to build on their expertise, hire, train, motivate, budget and reap rewards

Other Sources Employer Using to Hire

NA

Exclusive

NA

 




Job Order Requistion

Date of Request

8/7/2019

Position Title

Director of Statistics

Location (Town, Region)

Bridgewater

Employment Type

Full Time permanent

Travel %

50%

Travel Locations

Global Travel

Therapeutic Area

Autoimmune and Rare Diseases

Start Date

ASAP

First year income

$200k +

Degree Required

PHD

Years of professional and related experience

10 year

 

 

 

 

 

 

 

 

 

 

Requirements

 

 

 

Minimum Requirements

Education Required:

·         PhD in statistics or related field

Experience / Skills:

·        10+ years of experience in the pharmaceutical or biotechnology field

·         Strong oral and written communication skills

·         Demonstrated project and technical leadership qualities, and creative and strategic thinking required

·         Knowledge of FDA/CHMP guidelines, GCP, Clinical research, Fundamentals of Project Management, working in a matrix-based environment is a must.

·         Must be comfortable with hands on analysis of data using novel statistical techniques

Competencies:

·         Demonstrated expertise in advanced statistical methods (e.g. Adaptive designs, Bayesian methods, multiplicity, subgroup identification/data mining, predictive modeling etc.).

·         Functional knowledge of machine learning/AI and Big Data.

·         Experience in Modeling and Simulation in support of drug development programs

·         Ability to communicate with clarity and influence to drive change and innovation.

Organizational Relationship/Scope:

This position will work with multiple functions outside of Clinical Development. Key Stakeholders

·         Clinical Development TA Heads

·         Regulatory Affairs TA leadership

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Duties and Responsibilities

 

 

The Director, Statistical Innovation is responsible for providing statistical leadership in evaluating, developing and deploying advanced and novel statistical/analytical methodology and associated tools in Clinical Development. This leader proactively drives Development forward by providing strategic methodological and operational solutions to the most challenging clinical development problems. A strong individual contributor and a dynamic team leader, the Director of Statistical Innovation collaborates with statistical, clinical, and regulatory experts to broadly impact the portfolio by creating new ways to advance medicines to patients.

Principal Responsibilities

·         Deploy modeling and simulation capabilities and activities in support of drug development scenario planning and program optimization. Lead the discussion on modeling and simulation application and maximize the value of associated techniques

·         Provide consulting for statisticians and clinical teams.

·         Collaborate with different Department/Divisions to optimize clinical trial study designs and programs. Inform clinical development evaluations via modeling and simulation and other methodology as appropriate

·         Operate as a full partner to clinical and scientific leadership. Ensure effective partnership with other functions including clinical, regulatory, operation functions to drive quantitative decision making in drug development and enable successful impact on development programs and trials.

·         Serve as a leading representative engaging on external industry challenges like Adaptive Designs, data mining applications, advanced analytics and complex innovative designs. Represent MNK externally on advanced and emerging topics.

·         Educate statisticians and clinicians on emerging or existing advanced statistical methodology. Organize  statistical advisory boards with external experts. Explain complex methodological concepts to Senior leaders. Drive change through influence, negotiation and collaboration

·         Create tools  and platforms that operationalize key methodology making diverse approaches available to study teams