Job Description

Job Description Summary

Job Description

The Senior Statistical Programmer is responsible for developing, testing, maintaining, validating, and documenting data analysis programs that generate analysis datasets, tables, figures, and listings for clinical trials, regulatory submissions, and ad hoc project support. The clinical trials may be of moderate scope and complexity. Use programming knowledge to develop programming output that provides information in a very clear manner that crucial decisions can be made by the businesses or by the functions. Establish and maintain sound working relationships with other functional groups.

Primary Responsibilities and Duties

* Responsible for the integrity of the programming/computing solutions for all assigned projects.
* Support/Lead the full execution of final production output generation of quality, timely programming deliverables for statistical reports, CSRs, regulatory submissions, publications, and market promotions within the clinical projects.
* Generate analysis datasets, tables, figures, and listings for clinical trials, regulatory submissions, and ad hoc project support (e.g. publications and market promotions).
* Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad hoc requests.
* Ensure QC compliance and responsible for program records including archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality programming deliverables.
* Establish and maintain libraries of clear, fully documented and validated programs/macros, which are used and recycled.
* Identify and work to implement process improvement initiatives.
* Establish and maintain sound working relationships with other functional groups.

Qualifications

* Ability to program, document, and validate statistical software code in at least one statistical programming language, such as R or SAS, is required.
* 3+ years of experience of relevant experience in programming is required with a Bachelors degree in Computer Science, Statistics, or Life Sciences or 1+ years of experience with a Masters degree in Computer Science, Statistics, or Life Sciences.
* A minimum of a Bachelors degree required in Statistics, Computer Science, or Life Sciences or related field. Equivalent education or experience will be considered.
* Demonstrated competence in the application of statistical programming techniques used in clinical trials and regulatory submissions is required.
* Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH) is required.
* Basic understanding of statistical principals and analysis plans is required.
* Strong problem solving skills and attention to detail is required. Ability to recognize potential problems and take preventive steps. Ability to recommend solutions for more complicated or ambiguous issues for consideration. May lead an ad hoc team to resolve issues.
* Ability to identify process improvement opportunities within the function or across related functions and work or collaborate to implement them is required.
* Demonstrated capability of working on multiple projects at one time is required.
* Strong oral and written communication skills are required.
* Strong interpersonal skills are required. Specifically, cross-functional collaboration, listening, and negotiation skills are critical.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

LI-PRO

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift