Manager, Statistical Data Sciences Lead

Posted 9 Hours Ago
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Mumbai, Maharashtra
Hybrid
Senior level
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
The Manager, Statistical Data Sciences Lead will oversee statistical programming deliverables for clinical research, ensuring quality and compliance with Pfizer's processes. Responsibilities include project management, mentoring programmers, and collaborating with study teams to deliver analysis-ready datasets, tables, and figures. The role also involves guiding project standards and supporting clinical trial data reporting.
Summary Generated by Built In

QUALIFICATIONS / SKILLS
.

  • Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
  • At least (8-15) years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
  • Statistical Programming and SAS hands-on experience
  • Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data.
  • Good understanding of ICH and Regulatory Guidelines
  • Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations.
  • Thorough understanding of clinical data and relevant data standards
  • Extensive knowledge of routine statistical methodology and its application to programming
  • Knowledge of vendor processes
  • Demonstrated experience in developing successful partnerships within study teams
  • Strong written and oral communication skills, and project management skills
  • Ability to present technical information to a non-technical audience
  • Proven ability to operate independently.
  • Some exposure working across international boundaries and cultures.
  • Ability to manage customer expectations.
  • Ability to manage work of others in a remote and/or global setting


CDISC experience highly desirable
Responsibilities:

  • Individual Contributor/Project or Application Manager /People Manager of small teams
  • A highly productive, independent programming lead ensuring excellence in the delivery of analysis ready datasets, tables, listings, and figures to advance research, development, and commercialization of the Pfizer portfolio following Pfizer SOPs and processes
  • The programming point of contact at the study level, and will support at the asset/submission level (TA and Study ) , supporting end to end deliverables in the study/project/portfolio/standards team high complex statistical programming deliverables to support assets and study teams
  • Leading architecture development in Standards for major phases of delivery
  • Manage projects( mid and small sized) and/or manage small sized teams
  • Acts as co-lead/lead on selected projects/initiatives/ activities and also study deliverables as needed.
  • Guide, mentor, monitor programmers within the team and collaborate with Senior SDSL's on timelines, resource management and deliverables with quality.
  • Is capable of handling standards/study programming specific activities independently including collaboration across stakeholders at various timezones
  • Ensures adherence to high quality programming standards in their daily work
  • Ensure the tasks are completed on time with quality and are compliant to the process at Pfizer with needed guidance.
  • Work collaboratively with study teams and stakeholders such as clinicians and statisticians on milestones and deliverables.
  • Active self-learning and delivering on solutions in the space of statistical programming and data standards
  • Contribute to SDSA initiatives globally and locally.


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
#LI-PFE

Top Skills

SAS
The Company
HQ: New York, NY
121,990 Employees
Hybrid Workplace
Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.

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