Senior Statistical Programmer

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee one or more clinical trials in the capacity of a Senior or Lead Statistical Programmer.

• Create, sustain, and validate annotated Case Report Forms (aCRFs).

• Develop, maintain, and validate specifications and statistical programming for SDTM datasets, ADaM datasets, or derived datasets, as well as Tables, Listings, and Figures (TLFs).

• Prepare submission packages for DMC data review meetings, interim analyses, Clinical Study Reports, and other related purposes.

• Review and provide feedback on Statistical Analysis Plans, TLF Shells, and Data Management documents, including eCRFs and edit checks.

• Assist Data Management with data-cleaning tasks, which involve programming, reporting, reviewing, and resolving statistical data issues.

• Develop and maintain SDTM and ADaM define.XML/PDF files, clinical SDTM Reviewer’s Guides, and ADaM Reviewer’s Guides.

• Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21.

• Utilize global SAS macros to enhance programming efficiency.

• Serve as the Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and interim analyses.

• Collaborate with Biostatistical study teams and cross-functional departments to deliver high-quality work within established timelines and budgets.

• Contribute to and participate in internal initiatives pertaining to standard macros, templates, programming standards, and processes.

• Mentor junior Statistical Programmers as required.

• Stay updated with industry and CDISC standards, ICH guidance, and regulatory requirements.

⛳️ Requirements

• Bachelor’s degree in Statistics, Computing Sciences, or a related field; a master’s degree is advantageous.

• A minimum of 5 years of clinical research experience in the biotechnology, pharmaceutical, or Contract Research Organization (CRO) sectors, including 4 years in Statistical Programming and 1 year in a Lead Statistical Programmer role.

• Strong familiarity with clinical trial data, SAP, TLF Shells, and specifications.

• Proficient working knowledge of SAS; SAS certification is beneficial.

• Knowledge of XML programming is a plus.

• Comprehensive understanding of CDISC standards and guidelines; CDISC certification is advantageous.

• In-depth knowledge of the drug development process, ICH guidelines (including but not limited to ICH E6, E9, and E9(R1)), as well as relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, along with Pharmaceutical Industry Good Practices.

• Highly organized and detail-oriented, possessing effective project planning and time management skills.

• Ability to thrive in a fast-paced environment with a proven capacity to manage and prioritize multiple competing demands.

• Capable of working both independently and collaboratively within a team.

• Strong verbal and written communication skills in English; proficiency in French is a plus.

• Must be legally authorized to work in India.

🏝️ Benefits

• Permanent full-time position

• Flexible schedule

• Home-based position

• Ongoing learning and development

• Attractive advancement opportunities