Sr. Principal Statistical Programmer

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

POSITION

Senior Principal Programmer, Statistical

SUPERVISOR

Senior Manager, Programming or AD, Programming

DEPARTMENT

Programming (PRG)

PREREQUISITES

Bachelor's degree with 9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions; or 8 plus years experience with a MS/MA degree.

Responsibilities will include, but are not limited to, the following:

Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.

Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.

Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.

Ensure consistency and adherence to standards within their therapeutic area .

Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.

Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission.

Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.

Provide programming support for the preparation of integrated reports, submissions and post-submission activities.

Serve as the lead programmer in support of NDAs, sNDAs.

Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.

Provide training on departmental SOPs/WPs and standard programs.

Contribute to the creation of naming conventions and standards for the programming environment.

Routinely interface with cross-functional team members .

Influences other functions and represents as DOP technical expertise.

Represent as internal team leader who decides best course of action.

Coach and advise junior programmers to identify problems and solutions.

Oversee the services provided by CROs.

Skills/Knowledge Required :

Bachelor's degree in life science, statistics, mathematics, computer science, or related field is required; Master's degree is preferred.

9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor's degree; or 8 plus years experience with a MS/MA degree.

Demonstrated proficiency in using SAS to produce derived analysis datasets and produce TFLs.

Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.

Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).

Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.

Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.

In-depth understanding of regulatory, industry, and technology standards and requirements.

Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.

Demonstrated ability to work in a team environment with clinical team members.

Excellent planning and project management skills.

Good interpersonal, communication, writing and organizational skills.

Keep abreast of evolving regulatory, industry, and technology changes and demands, e.g., CDISC, SDTM, ADaM, eDC.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1526247_EN

Updated: 2020-06-15 00:00:00.000 UTC

Location: Seattle,Washington

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com