Associate Director, Statistical Programming:

Upper Gwynedd Pennsylvania
Requisition ID: STA000887

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 

Job Summary:

This position reports tothe Director, Statistical Programming (SP), within the Biostatistics and ResearchDecision Sciences (BARDS) organization and is a member of the Global Processand Standards (GPS) team. As a member of the GPS Team, the responsibilities ofthis position contribute to the Statistical Programming department and theoverall Quantitative Sciences organization in various ways. 

• The position manages statistical programming staff whose predominantaccountability is the development and review of randomization and component idschedule, as well as ongoing development and support related to provisioningfor unblinded analyses, and also statistical graphics support related toadvisory committee meetings, publications, and presentations.
• The position is responsible for hiring appropriate, qualified staff;conducting performance management and developing employees through coaching andmentoring, and training plan management.
• The position ensures appropriate and consistent development, training andapplication of SOPs, standards and quality and compliance measures related toallocation and component id schedule creation and study unblinding the nextgeneration patient data acquisition model.
• The position is responsible for implementing departmental objectives andmanaging resource and operational challenges.
• The position is responsible for staff resource management including resourceallocation and forecasting for its own area, and for contributing to resourcemanagement activities spanning the early and late-development areas.
• The position collaborates with the statistical programming project lead,statisticians and other project stakeholders in ensuring that project plans areexecuted efficiently with timely and high quality deliverables.
• The position provides technical and/or process guidance to employees andcolleagues for its area of accountability.
• The position contributes to departmental website development
• The position contributes to building and fostering group capability for thedelivery of expertise, and behaviors required to deliver success on projects
• The position engages with operational staff and partners globally

Key areas of focus include: 
• resource management 
• project prioritization
• interfacing with stakeholders and colleagues to ensure effective resourceallocation, deliverable development and execution
• membership on departmental strategic initiative projects 




.Education Requirement: 

BA/BS in Computer Science, Statistics, Life Sciences orrelated field, Preferred: MS or PhD

Required Experience and Skills**: 
• With a BA/BS 9  years experience in Statistics, SoftwareDevelopment, Clinical Data Management, Clinical Research, or Database Design& Development 
• With an MS, a minimum of (5) years experience inStatistics, Software Development, Clinical Data Management, Clinical Research,or Database Design & Development
• Broad knowledge and significant experience in developingand updating allocation and component ID schedules and related processes forclinical trials
• Strong project management skills with the ability to leadat a program level, determine an approach, ensure consistency and direct thedevelopment effort of others when opportunities arise
• Excellent written oral and presentation skills
• Excellent interpersonal skills and ability to negotiate andcollaborate effectively. 
• Strong collaboration, negotiation and organization skills.
• Ability to engage key stakeholders.
• Broad knowledge of clinical trials processes, datastructures and corresponding tools used to manage, extract, analyze &report data.
• Good working knowledge of reporting systems and standardreports capabilities
• Comprehensive knowledge of reporting processes (SOPs),regulatory requirements (e.g. 21 CFR Part 11) and software developmentlife-cycle (SDLC)
• Experience managing and forecasting programming resourcesat the project and therapeutic area level.
• Excellent communication and negotiation skills with ademonstrated history of teamwork and collaboration; deals well with change andseamlessly assimilates to new projects and stakeholders; ability to engage keystakeholders
• Strategic thinking - ability to turn strategy into tacticalactivities and operational objectives. 
• Ability to anticipate stakeholder and regulatoryrequirements

Preferred Experience and Skills:
• Six Sigma and/or Process Improvement CertificationExperiencewith MS Visio and MS Project
• Experience with developing training content including videos
• Website management

Job: Statistical Programming
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications