Director, Late Development Statistics

Job Description

Responsibilities:

• Supervises a group of statisticians in Late Development Statistics.

• Provides biostatistical and operational leadership to a team of statisticians in developing and coordinating statistical activities supporting drug/vaccine projects.

• Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and Scientists in long-range project planning, providing guidance to others in the statistical support for clinical drug/vaccine projects.

• Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.

• This position may serve as a statistical lead in project teams.

The incumbent may initially work in the therapeutic area(s) of cardiovascular, diabetes, endocrinology, or oncology.

Primary activities:

• Directs the scientific and technical development of statisticians. Encourages staff to conduct statistical research and publish/present scientific findings/methodologies. Mentors and guides junior staff in functional activities. Encourages staff to conduct statistical research and other non-project activities.

• Performs managerial, administrative duties including coaching, performance evaluation, expense report approval consistent with grant of authority

• Directs recruiting effort to hire qualified statisticians

• Directs biostatistical support required for assigned projects

• Serves as lead statistician in cross-functional teams for the strategic planning and execution for product development and worldwide regulatory submissions

• Lead a team of statisticians and the statistical programmers to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements

• Represent statistics in meetings with management in strategic planning of projects

• Represent statistics in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies

• Ensures the statistical designs and analysis methods utilized in clinical studies are scientifically sound and meet worldwide regulatory and marketing needs

• Perform comprehensive review of protocols, statistical analysis plans, clinical study reports, and submission documents to insure accuracy of the statistical content

• Provides effective and efficient statistical oversight and ensures consistency of methodology

• Coordinates statistical project assignments and resource allocation with other managers

• Identifies needs for new statistical techniques

• Involved in research activities for innovative statistical methods and applications in clinical trial development.

Education & Skills

Required Education and Minimum Requirement:

• PhD or equivalent degree in statistics\biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master’s degree with a minimum of 12 years relevant work experience.

Required Skills and Experience:

• Prior supervisory and project management experiences are necessary.

• Solid knowledge of statistical analysis methodologies, clinical trial designs, and statistical and data processing software, e.g., SAS and/or R.

• Solid knowledge of worldwide regulatory requirements and clinical trial expertise from phase II to V.

• Excellent oral and written communication skills.

• Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.

Preferred Skills and Experience:

• Publications in peer reviewed statistical/medical journals.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

BARDS2020

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms 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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R125879