Contract Sr. SAS Programmer- San Diego Job at SimulStat's Client, San Diego, CA

elR4ZzV4Myt6N3FtaVVqVFE5eVdNQnlSZkE9PQ==
  • SimulStat's Client
  • San Diego, CA

Job Description

Onsite - San Diego 12 month renewable contract 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.
  • Perform programming validation to ensure the quality of analysis datasets and programming outputs.
  • Ensure consistency and adherence to standards within the project.
  • 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.
  • Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
  • Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
  • Serve as the lead programmer in support of NDAs, sNDAs.
  • Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables.
  • Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.
  • Contribute to the creation, maintenance, and validation of standards for outputs and macros.
  • Provide training on SOPs, WPs and standard programs.
  • Contribute to the creation of naming conventions and development of the programming environment.
  • 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.
  • 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions.
  • Demonstrated proficiency in using SAS to produce derived analysis datasets and 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.
  • Good planning and project management skills.
  • Good interpersonal, communication, writing and organizational skills.

Job Tags

Contract work, For contractors, Flexible hours,

Similar Jobs

Dominique Ansel Bakery

Pastry Sous Chef Job at Dominique Ansel Bakery

 ...restaurant with a focus on pastry, with at least 2 years of having managerial responsibilities A genuine passion and knowledge for food and pastries Culinary school attendance Prior experience with laminated dough, cakes, ice cream, chocolate, and sugar work... 

Elderwood

Business Office Assistant Job at Elderwood

Salary:$16.51 - $19.35Overview: We are seeking a full time Business Office Assistant to join our team. Experience inside of a healthcare facility is a PLUS! The Business Office Assistant supports the Business Office Coordinator and the daily operations of the business... 

Luxury Bath NJPA

Sub-Contractor - Bathroom Remodeling Job at Luxury Bath NJPA

 ...CALL :(***) ***-**** for immediate consideration Bathroom Remodeling Installers / Independent Contractors Carpentry & Plumbing Luxury Bath NJPA is hiring independent contractor bathroom installers for high-volume bathroom remodeling projects . We are looking... 

Novastar Prep Tutoring

Tutor Online- All Subjects Needed! Job at Novastar Prep Tutoring

Are you passionate about making a difference in students lives? Novastar Prep is seeking dedicated part-time tutors to join our team. Whether you're an experienced educator or someone with a strong academic background, this is your opportunity to work 1:1 with students...

Openkyber

Nexus Job at Openkyber

 ...adoption of Scaled Agile practices across global teams. Proficient and certified in agile at scale methodologies such as SaFE, LeSS, Nexus etc. Ability to clearly articulate objectives and influence outcomes Excellent verbal and written communication skills...