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Statistical Programmer

75% Flex
Remote: 
Full Remote
Experience: 
Senior (5-10 years)
Work from: 
Connecticut (USA), Illinois (USA)

Offer summary

Qualifications:

Bachelor's or Master's degree in biostatistics or computer science, 8+ years of experience as a Lead Statistical Programmer in biotech/pharmaceutical.

Key responsabilities:

  • Generate SDTM and ADaM datasets, tables, listings, and figures
  • Review statistical analysis plans, TLF specifications, CRFs, and study data documents
  • Prepare study reports, regulatory submissions, safety update reports
  • Conduct additional data analysis and validations
  • Collaborate with CRO programmers, contribute to process improvement initiatives
Katalyst HealthCares & Life Sciences logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
About Katalyst HealthCares & Life Sciences
Katalyst Healthcare's & Life Sciences (Katalyst HLS) is a Global Contract Research Organisation that provides End-to-End Clinical Research Services for Healthcare and Life Sciences companies globally. At Katalyst HLS offers ICH-GCP compliant clinical trial services from Phase I–IV in all key therapeutic areas to support clinical development and research requirements and also provides validation, quality and regulatory services for Pharma/Bio-Pharma/Medical Device industries. Services:- Clinical Trial Management- Clinical Data Management- Biostatistics & Statistical Programming- Medical Writing- Pharmacovigilance- Quality and Regulatory Affairs- GMP, GLP and GCP Validations- Manufacturing Process Validations- Equipments & Instruments Validations- Computer Systems Validations- Human Resourcing
See more Katalyst HealthCares & Life Sciences offers

Job description

Logo Jobgether

Your missions

Responsibilities:
  • Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/Client to FDA, EMA, and other worldwide regulatory agencies.
  • Participate in the review of statistical analysis plans and TLF specifications.
  • Review or annotate CRFs for SDTM mapping, review/author SDTM/ADaM dataset specifications.
  • Review, and comment on CRFs, vendor data transfer specifications (DTS), edit checks and other study data related documents.
  • Support in the preparation of study reports, regulatory submissions, and annual safety update reports.
  • Perform additional analysis and validation for data checking, publication, presentation, poster, and ad hoc analysis.
  • Work with CRO statistical programmers and perform statistical programming vendor oversight.
  • Contribute to Biometrics SOPs and work instructions related to EDC studies, FDA requests, and statistical programming processes.
  • Contribute to department process improvement initiatives.
  • Support department infrastructure build up by developing, validating, and testing the macros, utilities, and tools.
  • Keep abreast of literature and advancements in SAS.
Requirements:
  • Bachelor's or master's degree in biostatistics, computer science, or related fields, Master's degree preferred.
  • At least 8+ years of relevant experience, including as a Lead Statistical Programmer, in the biotech or pharmaceutical industry.
  • The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
  • Proficient of SAS programming in a regulated clinical research environment.
  • Experience of programming and validation of SDTM and ADaM data sets, tables, figures, and listings.

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

SASMeeting Scheduling

Soft Skills

  • Effective Communication
  • Prioritization
  • Team Collaboration
Are you interested?

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