Merck & Co Hiring for Executive Director, Study Data Standards and Quality Management job in North Wales Full Time

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the-art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.- Responsibilities : Reporting to the head of Statistical Programming (SP), the Executive Director of Study Data Standards and Quality Management (SDSQM) provides leadership for the successful implementation of SDTM data deliverables required for analysis, reporting, and regulatory submission and provides advisement to ensure study data deliverables are compliant with regulatory agency requirements and expectations.- The Executive Director is a critical member of the Statistical Programming Leadership Team, accountable for a diverse team of CDISC data standards experts, sets the strategic and operating direction for the SDSQM team, and effectively collaborates with stakeholders at all levels in Biostatistics, Clinical Research, Data Management, Regulatory Affairs, and IT.

Primary Activities :

• Manages managers; builds great teams; recruits and hires staff; performs performance reviews; conducts talent management; develops employees; advocates for team at the functional leadership level; coaches and mentors staff; participates in succession and workforce planning
• Determines the BARDS analysis and reporting strategy at a therapeutic level or across several therapeutic levels; works in partnership with Statistical and SP leaders; accountable for the data standards deliverables and is the point of escalation during conflicts and issues; manages work according to MRL scorecard; collaborates with stakeholders; interface with functional service partner(s)
• Stays current with regulatory guidance and submission standards
• Manages team’s headcount and budget; engages with vendors to develop and maintain flexible and cost-effective programming resources
• Leads departmental and strategic initiative projects; develops and implements long-term and annual strategic and operating objectives for designated areas of responsibility with Statistical Programming
• Actively participates in external industry initiatives; engages with external SP thought leaders and regulatory leaders in areas of mutual interest, including contributing to, organizing or chairing research sessions at professional meetings

Education and Minimum Requirement :- A master’s degree in statistics, computer science or closely related field is preferred. The position requires at least 10 years of experience in statistical programming, statistics, or closely related activity in a pharmaceutical development environment and at least 5 years of management experience at the Director level.- Required Skills and Experience:- Excellent oral and written communication skills. Ability to collaborate and negotiate effectively with stakeholders.- Ability to function effectively in a dynamic, fast-paced environment, and to make sound, timely business decisions.- Experience collaborating with statisticians, regulatory, and data managers. Experience working in a global environment and communicating with staff in different regions of the world.- Experience working with external vendors for resources and software. -Preferred Skills and Experience:

• Superior knowledge and prior experience in setting strategy around the development of efficient standards for analysis and reporting and submission deliverables
• Strong knowledge and understanding of CDISC data standards-
• Experience managing or supervising a team of statistical programmers in developing analysis and reporting programming deliverables; experience in recruiting and hiring, performance evaluations, & people development
• Solid experience with reporting processes, regulatory requirements, and software development life cycle
• Strategic thinking – ability to effectively lead a team when faced with new or changing technology, standards, requirements, processes and competing priorities; ability to respond with urgency to implement impactful, yet practical, programming solutions
• As a member of the Statistical Programming Leadership team, actively participate and contribute to setting the vision and strategy for the department
• Excellent interpersonal skills and ability to prioritize, negotiate, and work across boundaries as one team
• Excellent project management skills; leadership across multiple and complex programs; determines strategy and ensures consistency and compliance, ability to engage other stakeholders
• Ability to anticipate stakeholder needs and requirements
• Experience managing other managers–

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). -Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Under New York City, Colorado State, Washington State, and California State 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:
$213,280.00 – $335,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. – For Washington State Jobs, a summary of benefits is listed here .

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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.-

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
Yes

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st – Day

Valid Driving License:
Yes

Hazardous Material(s):
No

Requisition ID:R249352