Statistical Programming Director (Hybrid PA/NJ)
Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.
We are seeking a Growth and Improvement minded Statistical Programming Director that can help drive our Strategic Operating Priorities.
Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
Summary, Focus and Purpose
The BARDS Statistical Programming Director navigates both people and project management responsibilities and is accountable to set strategy for the delivery of high-quality and compliant statistical analysis and reporting.
Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Direct the activities of programmers whose predominant accountability is the development, validation, and execution of programs creating analysis datasets, tables, listings, figures, and submission deliverables for drug and vaccine programs
Interact with cross-functional Research & Development Division scientists including, Statistics, Clinical, Regulatory, QP2, CSRM, Data Management, and Statistical Programming to plan for the statistical analysis and reporting of clinical drug and vaccine projects
Set direction for the analysis and reporting deliverables | Negotiate and prioritize resource assignments with staff and stakeholders at a regional or global level ensuring that project plans are executed efficiently with timely and high-quality deliverables
Manage the analysis and reporting deliverables of Functional Sourcing Partners
Ensure appropriate and consistent application of SOPs, standards, and quality and compliance measures
Engage with cross-functional stakeholders to identify areas for improvement and solve business challenges; Establish strong partnerships with statistical stakeholders in BARDS LDS, EDS, CSS
Provide technical and/or scientific guidance to employees and colleagues
Manage staff resources including resource allocation and forecasting; identify solutions to address resource and operational challenges
Contribute to building and fostering group capability for the delivery of expertise, and behaviors required to deliver success on projects
Hire appropriate, qualified staff
Complete performance management and employee development including coaching and mentoring
Manage training plans
Lead and actively contribute to departmental strategic objectives
Represent Statistical Programming at a leadership level; be a visible contributor and decision maker
Interface externally in industry activities
Bachelor's or Master's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering
Bachelor with twelve to fifteen years SAS programming in a clinical trial environment or Master with ten plus years SAS programming in a clinical trial environment
Seven plus years of project management in the development and execution of statistical analysis and reporting deliverables
Prior people management experience with demonstrated ability to lead and develop people
Expertise managing and forecasting programming resources at the project and therapeutic area level
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, systems and databases including advanced knowledge of CDISC data standards
US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of submission deliverables
For directors in ESD, a deep understanding of ESD business needs and regulatory requirements
Knowledge of regulatory agency requirements pertaining to statistical computing and programming issues
Principled 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
Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
Experience leading the activities of a programming team that includes functional sourcing partners, domestic contractors, and global resources; ability and interest to work across cultures and geographies
Three plus years managing a team of statistical programmers; completing people management responsibilities including both performance and talent management activities
BARDS Statistical Programming management experience
Demonstrated ability to handle change management; influence and drive strategies for implementation in operational area and collaborate with other leaders
Demonstrated success in championing and driving proficiency and compliance with standard processes
Strategic thinking - ability to turn strategy into tactical activities and operational objectives; Demonstrated experience leading strategic and departmental initiatives
Familiarity and ability to comprehend statistical analysis methods and clinical data management concepts
Ability to anticipate stakeholder and regulatory requirements
Demonstrated ability to work across cultures and geographies
Active in professional societies
Experience in process improvement
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., Rahway, 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 …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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.
Residents of Colorado
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Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected salary range: 157,700 - 268,200.
For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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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.
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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.
Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:$157,700.00 - $268,200.00
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.
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Number of Openings:1