193 applicants

Company

Rho · 1 day ago

Senior Statistical Programmer I

United States

Full-time

Remote

Mid, Senior Level

$110K/yr - $125K/yr

4+ years exp

Maximize your interview chances

BiotechnologyHealth Care

Actively Hiring

Hiring Manager

Jennifer Hunt

Insider Connection @Rho

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users

Use your expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design

Use study protocol, CRF, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implementation guides to independently author SDTM specifications from scratch; use Pinnacle 21 to run data conformance and create define.xml for SDTM and ADaM submissions

Act as the CDISC subject matter expert

Convert designs and specifications into computer code and analyze code to find causes of errors and revise programs

Write and maintain documentation of changes to computer code, programs, and specifications

Review user and technical documentation written by others to confirm consistency with program operations

Offer expertise relevant to statistical programming and CDASH data collection for study start up, execution, and close out: review protocols, draft CRFs; prepare and review validation plans, review vendor DTAs, etc

Modify and maintain software programs written by others

Provide mentorship and training to peers and more junior programmers in areas of expertise

Ensure effective, accurate and timely communication of key issues and progress to the team and Sr. Management

Perform functional lead activities on assigned projects while maintaining scope and budget oversight

May provide guidance and input to the budgets and business submissions of proposals

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

SAS programmingSDTM modelADaM modelClinical trials knowledgeData conformance toolsClinical Practice (GCP)International Conference on Harmonization (ICH)Define.xml creationCommunicatorCommitted to QualityHigh-CharacterCritical ThinkerAgile

Required

BA/BS in computer science, statistics, or related field along with 4-5 years performing statistical programming in the SAS language within the CRO/Pharmaceutical industry

Extensive experience and understanding in SDTM model including transforming raw data files while adhering to CDISC standards from end to end (raw data to eSub); advanced understanding of SDTM model and experience with both specification, programming, and conformance of SDTM CDISC; strong CDISC skills with an emphasis on SDTM End to End submissions experience

ADaM model and experience with both specification, programming, and conformance of ADaM CDISC is a plus

SAS/Base knowledge with an emphasis on data step programming; competency modifying pre-existing SAS code, as well as writing SAS code from specs.

Clinical trials including knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Data/submission conformance tools (such as P21), creation of define.xml, SDSP, and study data reviewer’s guides

Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.

Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.

High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust.

Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience.

Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment.