Pfizer

Associate Director, Clinical Data Standards Strategist, Standards and Data Conformity

Employer
Pfizer
Location
La Jolla, California; Collegeville, Pennsylvania; Groton, Connecticut
Salary
Competitive
Posted
January 20 2021
Ref
4801934
Position Type
Full Time
Organization Type
Pharma
Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

It is our mission to lead and drive data standards, quality improvement and regulatory compliance to support Global Biometrics and Data Management (GBDM) in delivering the highest possible quality data outputs. You will play an important role in assisting statisticians, statistical programmers and data scientists optimize and maintain the integrity of clinical trial data standards. You will be relied on to help influence study teams to successfully operate within the data standards framework.

As a Clinical Data Standards Strategist you will provide strategic direction and operational oversight to ensure the quality and consistency of clinical trial data standards to support the portfolio in one business category. Your knowledge and decision making will enable study teams to achieve high levels of data quality and consistency across programs and systems which in turn will help all GBDM functional lines deliver with excellence. You will have the opportunity to network with vendors and globally diverse colleagues as you deliver data standards that drive Pfizer's efficiency and compliance to industry regulations. In acting as Key Opinion Leader and Subject Matter Expert within the clinical data standards arena, both internally and externally, you will contribute to improvements in how clinical data standards can be optimally developed, maintained and utilized within GBDM.

It is your commitment and hard work that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Collaborate with GBDM functional line roles, cross-functional study team members and other functional lines to create data standards solutions that support the scientific need of a business unit/ category/ therapeutic area while ensuring quality, consistency and compliance to CDISC standards that supports the exchange of data.
  • Serve as a subject matter expert on all aspects of standards development that includes industry standards (CDISC), regulations, legal mandates, processes, and business policies.
  • Key member of the global and Therapeutic Area (TA) standards governance boards to define, maintain and enforce standards in all GBDM functional areas for one research category to ensure consistency across studies.
  • Ensure work is carried out in accordance with applicable SOP's and working practices.
  • Key data standards contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups with Pfizer.
  • Directly support knowledge development across all GBDM functional lines as a subject matter expert on data standards, educating on change control management and related tools/applications.
  • Create metrics and other measures to ensure and optimize compliance with standards.
  • Accountable for creation, maintenance and delivery of enterprise level training for clinical trial data standards processes and tools
  • Anticipate, oversee and influence business drivers to maintain efficient, high quality decision making and operational delivery
  • Facilitate a culture of continuous process improvement and a high level of customer service by maintaining and improving the standards processes associated with standards creation, maintenance, decision-making and implementation across GBDM functional lines.
  • Support and Implement future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externally consumers.


Qualifications

Must-Have
  • Bachelor's degree in a scientific discipline. Master's degree in Statistics, Computer Science preferred.
  • At least 10 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency. Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementation preferred. Experience in the areas of design, support of large scale distributed databases and data standards administration.
  • Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements
  • Demonstrated experience managing multiple tasks, complex projects and working with cross-functional teams delivering to project and portfolio timelines and metrics.
  • Strong verbal and written communication skills; independent and effective working in a multi-study, multi-disciplinary atmosphere in an matrix environment
  • Significant clinical data management (Oracle RDC/InForm preferred), statistical programming, and/or trial management experience with technical expertise in standards implementation. Strong experience in clinical data management systems and/or the generation of statistical programming deliverables
  • Experience using relational databases preferred (e.g. MDR, MS SQL Server, MS Access, or Oracle)
  • Experience developing standards strategies and leading cross-functional implementation.
  • Demonstrated ability to build strong network/knowledge/relationships with internal/external stakeholders
  • Ability to think critically, understand complex medical information and constructively challenge scientific experts both internally and externally.
  • Strong written and verbal communication skills, leadership, decision-making, influencing and negotiating skills.
  • Expert knowledge, experience and expertise in clinical trial development


Nice-to-Have
  • Master's degree in Statistics, Computer Science or related field or equivalent experience preferred.
  • Preference provided to those with demonstrated project management experience.


PHYSICAL/MENTAL REQUIREMENTS
  • Primarily an office-based position involving sitting in front of a computer for large periods of work time, making presentations, etc.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Ability to travel approximately 5%


Other Job Details:
  • Last Date to Apply for Job: January 8th
  • Eligible for Employee Referral Bonus: YES


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Sunshine Act

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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