Pfizer

Clinical Data Standards Strategy Lead (Director), Standards and Data Conformity

Employer
Pfizer
Location
New York City, New York; Collegeville, Pennsylvania; Groton, Connecticut
Salary
Competitive
Posted
November 17 2020
Ref
4799300
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

As part of the Standards and Data Conformity (SDC) group, an integral strategic and quality-focused unit within the Global Biometrics and Data Management (GBDM) organization, you will serve as the primary point of contact for clinical trial data collection, analysis, and reporting standards for one or more business units/categories/therapeutic areas. You will provide strategic direction and operational oversight of delivery of standards projects to meet the business and portfolio requirements across GBDM functions.

As a Clinical Data Standards Strategy Lead, you will be accountable for the cohesive strategic vision and alignment of clinical trial data standards towards the ultimate objective of data quality and consistency in across programs and systems from the authoring of the Clinical Development Plan through to the Clinical Study Report. You will be accountable for optimizing statistical, programming and data management functional areas in GBDM to develop and maintain the timely and high-quality delivery of clinical trial standards in support of the Pfizer portfolio.

You may have direct reports and be asked to provide line management responsibilities including professional and technical development of staff, as well as workload and resourcing prioritization. Additionally, you will serve as a Key Opinion Leader and Subject Matter Expert within the clinical data standards arena, both internally and externally and lead improvements in how clinical data standards can be optimally developed, maintained and utilized within GBDM while influencing standards-aligned behaviors across Pfizer.

It is your dedication and focus that will help make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Develop and implement standards strategies to align with and enable overall business strategies through leadership in guiding global and Therapeutic Area (TA) standards governance boards that define, maintain and enforce standards across the Business Units to ensure consistency across studies.
  • Design clinical trial data standards is optimized from protocol to clinical study report, with a focus on the areas of data acquisition at the investigative site thru the generation of tables, listings and figures including the use of appropriate flexibility in data standards specification as well as the effective use of technology.
  • Drive high performing cross-GBDM data standards teams in order to deliver CDISC compliant clinical trial data standards and provides expertise to the Research/Business units, Global Product Development (GPD) lines in a high quality and timely manner.
  • Be accountable for the quality, management and governance of clinical trial data standards from protocol to clinical study report.
  • Contribute to the design of business activities that support the integration of clinical trial data standards (legacy Pfizer data, external data, and other data sources).
  • Anticipate, oversee and influence business drivers to maintain efficient, high quality decision making and operational delivery.
  • Develop and implement processes, metrics & other measures to create, support and drive clinical trial data standards activities across Pfizer GPD and Worldwide Research & Development (WRD).
  • Develop creative solutions to complex problems within and beyond scope of expertise while managing risks appropriately to enable innovative solutions.
  • Establish strong partnerships within and across the functional lines in GBDM as well as with each of the GPD lines and external CDISC and/or PhUSE teams for the implementation and use of data standards across the clinical trial continuum (processes, systems).
  • Ensure all clinical trial data standards activities comply with relevant SOPs and work instructions, CDISC, Pfizer policy and relevant global regulatory requirements in order to deliver acceptable submissions to regulators requiring industry standards.
  • Create, maintain and deliver enterprise level training for clinical trial data standards as well as operational constructs that improve cross-functional collaboration at the study level that improve clinical trial data standards understanding and usage.
  • May act as delegate for GBDM co-lead of Clinical Data Standards Global Governance Board.


Qualifications

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Must-Have
  • Bachelor's degree or higher in a scientific discipline is preferred.
  • Minimum 10 to 15 years of experience in the Pharmaceutical industry including an understanding of the drug development process with 5 years in team leadership roles.
  • Significant clinical data management, 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.
  • Strong experience developing standards strategies and leading cross-functional, enterprise-wide-scoped implementation.
  • Expert knowledge, experience and expertise in clinical trial development.
  • Demonstrated ability to build strong network/knowledge/relationships with internal/external stakeholders.
  • Practical experience as a business process owner interfacing and achieving concordance with multiple customers.
  • 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.
  • Knowledge of clinical research, FDA, ICH, CGP, related regulatory requirements, and knowledge of CDISC required.


Nice-to-Have
  • Master's degree in Statistics, Computer Science or related field
  • 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 10% to 25%


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


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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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