Statistical Programming Lead (Standards) – Senior Manager
- Employer
- Pfizer
- Location
- Working from Home
- Start date
- May 16, 2022
View more
- Discipline
- Information Technology, Bioinformatics
- Required Education
- Bachelors Degree
- Position Type
- Full time
Works with statisticians, programming resources, and other colleagues as appropriate to ensure clear specifications needed to develop standard CDISC compliant software
Hands on experience developing CDISC ADaM analysis ready datasets and supporting tables, listings, and figures
Ensures adherence to Pinnacle 21 CDISC validation checks
Working understanding of software development lifecycle (SDLC) practices
Accountable for the management and delivery of assigned work
Provide oversight and guidance to Pfizer standards programming team and contract resources
In addition to management of the deliverables, the senior lead will also provide consultation to the asset/submission teams with respect to planning of programmed asset deliverables as well as standards strategy
Ensures adherence to high quality programming standards documentation
Role Responsibilities:
May have people management responsibilities
Will be a mentor to junior colleagues
Excellent communication skill to ensure appropriate collaboration with statisticians, data managers, statistical programmers, clinical pharmacology leads, research data scientists and programming leads to ensure clear specifications for their programmed deliverables are in place
Provide solutions to complex programming issues using problem solving skills and previous experience
Will contribute to and may lead department level initiatives. May also contribute to broader initiatives outside of the department
Represents Programming Standards within Global and TA Standards Boards
Represent Pfizer within industry forums (i.e., PhUSE, CDISC, Transcelerate, …)
Qualifications:
Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field
At least 5 years relevant statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
Advanced statistical programming expertise using SAS (i.e., ODS, Base SAS, Macro Language, Statistics and Graphics)
Knowledge of CDISC is required
Cross Therapeutic Area experience highly desirable (Primary Areas of Interest: Oncology, Vaccines, I&I)
Knowledge of R and/or Python are highly desirable
Clinical trials data flow expertise from data collection through reporting
Adept at solving problems
Experience working with a global programming team is highly desirable
Demonstrated experience managing complex projects
Strong written and oral communication skills, leadership, decision making, influencing, negotiation, and project management skills
Proven ability to operate independently in ambiguous situations
Proven ability to present technical information to a non-technical audience
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#LI-Remote
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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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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