1+ months

Statistical Programming, Standards (Senior Associate)

Pfizer
San Jose, CA 95112 Work Remotely
**Role Summary**



+ Accountable for the quality and timely delivery of enterprise level standard statistical programming encompassing the following areas: CDISC ADaM, and TLF generation

+ In-depth knowledge of standards development framework and reporting environment

+ Experience working through the development and release process outlined within the standards software development lifecycle (SDLC) practices and SOPs

+ Ensures appropriate documentation is generated to support audit readiness in defense of our standard software development

+ Works with statisticians, programming resources, and other colleagues as appropriate to ensure clear specifications for the standard software development

+ Excellent understanding of CDISC IG requirements, NCI Control Terminology, and programming of analysis ready datasets, tables, listings, and figures for which they are responsible

+ Ensures adherence to Pinnacle 21 CDISC validation checks and high quality programming standards in their daily work

+ Ensures adherence to high quality programming standards in the production of clinical reports and submission documentation



**ROLE RESPONSIBILITIES**



+ Will be a mentor to more 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

+ Will be knowledgeable of software development practices as defined within Pfizer's CDISC development framework

+ Provides solutions to complex programming issues using problem solving skills and previous experience

+ Bachelor Degree in Statistics, Biological Sciences, IT, or related field

+ At least 2 years relevant statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency

+ Statistical Programming and R hands-on experience

+ Excellent technical skills and advanced knowledge in R.

+ Demonstrated experience in developing, maintaining and deploying R Shiny application in production.

+ Knowledge of Base R

+ Working Knowledge of the following packages highly desirable Tidyverse , Ggplot2, DPlyr, Tidyr, Readr

+ Working knowledge of R Markdown , Knitr, and kable highly desirable

+ Knowledge of purr , tibble, stingr, forcats is desirable

+ Working knowledge of Base SAS, SAS macros and SAS graphical utilities highly desirable

+ Clinical trials data flow expertise from data collection through reporting

+ Adept at solving problems using skills based on experience and extrapolation to new situations.

+ Understanding of clinical data and relevant data standards

+ Ability to manage customer expectations, anticipate potential objections, and influence others

+ CDISC ADAM experience required

+ Real World Data & Evidence experience desired



**Qualifications**



+ Bachelor Degree in Statistics, Biological Sciences, IT, or related field

+ At least 2 years relevant statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency

+ Statistical Programming and R hands-on experience

+ Excellent technical skills and advanced knowledge in R.

+ Demonstrated experience in developing, maintaining and deploying R Shiny application in production.

+ Knowledge of Base R

+ Working Knowledge of the following packages highly desirable Tidyverse , Ggplot2, DPlyr, Tidyr, Readr

+ Working knowledge of R Markdown , Knitr, and kable highly desirable

+ Knowledge of purr , tibble, stingr, forcats is desirable

+ Working knowledge of Base SAS, SAS macros and SAS graphical utilities highly desirable

+ Clinical trials data flow expertise from data collection through reporting

+ Adept at solving problems using skills based on experience and extrapolation to new situations.

+ Understanding of clinical data and relevant data standards

+ Ability to manage customer expectations, anticipate potential objections, and influence others

+ CDISC ADAM experience required

+ Real World Data & Evidence experience desired



**Nice-to-Have**



+ Master's degree

+ Relevant pharmaceutical industry experience

+ Experience using data visualization tools

+ Proficient experience using commercial clinical data management systems and/or EDC products

+ Awareness of regulatory requirements and relevant data standards



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Ability to start early hours 7 to 8 AM US Eastern time to accommodate meetings with India time zone



Other Job Details:



+ Eligible for Relocation Package: NO

+ Eligible for Employee Referral Bonus: YES

+ \#LI-PFE



**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.**



**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**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.



Medical

Categories

Posted: 2022-03-28 Expires: 2022-06-01

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Statistical Programming, Standards (Senior Associate)

Pfizer
San Jose, CA 95112

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