Merck Associate Director, Statistical Programming - Late Stage Oncology in Rahway, New Jersey

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.

This position manages programmers responsible for statistical programming activities for multiple late stage (phase II - IV) Oncology clinical development projects, in one or multiple indication in this TA.

The incumbent is responsible for implementing departmental objectives and managing resource and operational challenges

The position ensures appropriate and consistent application of SOPs, standards and quality and compliance measures

Provides technical and/or scientific guidance to employees and colleagues.

Contributes to building and fostering group capability for the delivery of expertise, and behaviors required to deliver success on projects. Collaborates with the Statistical Programming project lead, statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables

Position is responsible for hiring appropriate, qualified staff; performance management and employee development including coaching and mentoring; training plan management. Manages programmers whose predominant accountability is the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.

For assigned projects the incumbant is responsible for staff resource management including resource allocation and forecasting. In addition the position contributes to resource management activities that span the entire late stage Oncology development area (LSD Group2).

Key areas of focus include (1) resource management (2) project prioritization (3) interfacing with outsource partner management to ensure effective resource allocation and deliverable development and execution (4) membership on departmental strategic initiative projects (5) interfacing externally in industry activities.

Education Minimum Requirement: Bachelors or Master's (preferred) Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering

Required Experience and Skills: BS plus 9-12 years or MS plus 7 years SAS programming experience in a clinical trial environment

Experience managing a team of statistical programmers in the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures) in one or multiple therapuetic areas (TA).

Broad knowledge and demonstrated experience in developing analysis and reporting statistical programming deliverables using global and TA standards and according to quality, compliance and timeliness requirements.

Expertise in SAS and clinical trial programming including data steps and procedures; systems and database expertise; Familiarity with statistical analysis methods and clinical data management concepts.

Knowledge of regulatory agency requirements pertaining to statistical computing and programming issues.

Experience managing and forecasting programming resources at the project and therapeutic area level.

Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders; ability to engage key stakeholders

Strategic thinking - ability to turn strategy into tactical activities and operational objectives.

Ability to anticipate stakeholder and regulatory requirements

Experience in mentoring programmers at different levels and conducting performance management

Preferred Experience and Skills:

US and/or worldwide Oncology/Drug regulatory application submission experience at the leadership level including the development of electronic submission deliverables.

Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)

Ability and interest to work across cultures and geographies.

Experience leading the activities of a programming team that includes outsource-partner, contractor, and global resources.

Ability to complete statistical programming deliverables through the use of global outsource partner programming staff

Experience developing and managing a project plan using Microsoft Project or similar package

Experience contributing to project resource allocation and forecasting activities at the late-stage development portfolio level.

Experience in CDISC and ADAM standards.

Active in professional societies

Experience in process improvement

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

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Job Statistical Programming

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Other Locations: NA-US-NJ-Rahway

Title: Associate Director, Statistical Programming - Late Stage Oncology

Primary Location: NA-US-PA-Upper Gwynedd

Requisition ID: STA000923