Senior Statistical Programmer

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

📋 Description

• Oversee one or several clinical trials as the Lead Statistical Programmer.

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

• Design, maintain, and validate specifications and statistical programming for SDTM datasets, ADaM datasets, or derived datasets, along with Tables, Listings, and Figures (TLFs).

• Assemble submission packages for DMC data review meetings, Interim Analyses, and Clinical Study Reports.

• Review and contribute to Statistical Analysis Plans, TLF Shells, eCRFs, edit checks, and other Data Management documents.

• Facilitate data cleansing by programming, reporting, reviewing, and resolving statistical data issues.

• Develop and validate SDTM and ADaM define.XML/.PDF files and reviewer guides.

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

• Employ global SAS macros to enhance programming efficiency.

• Serve as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and Interim Analyses.

• Engage in and contribute to internal initiatives related to standard macros, templates, programming standards, and processes.

• Collaborate with Biostatistical study teams and other departments to ensure high-quality deliverables within deadlines and budget constraints.

• Ensure adherence to ICH guidelines, pharmaceutical industry standards, regulatory requirements, and company SOPs.

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

• Mentor junior Statistical Programmers as necessary.

⛳️ Requirements

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

• Minimum of 5 years of clinical research experience within the biotechnology, pharmaceutical, or Contract Research Organization (CRO) sectors.

• At least 4 years of experience in Statistical Programming.

• Minimum of 1 year in the role of Lead Statistical Programmer.

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

• Proficient in SAS; SAS certification is a plus.

• Familiarity with XML programming is advantageous.

• In-depth knowledge of CDISC standards and guidelines; CDISC certification is a plus.

• Comprehensive understanding of the drug development process, ICH guidelines, relevant Health Canada and FDA regulations, guidelines, electronic data submission requirements, and Pharmaceutical Industry GPP.

• Highly organized and detail-oriented, with effective project planning and time management capabilities.

• Ability to thrive in a fast-paced environment and manage multiple competing priorities.

• Capable of working independently as well as part of a team.

• Strong verbal and written communication skills in English; proficiency in French is an asset.

• Must possess legal eligibility to work in the Philippines.

🏝️ Benefits

• Permanent full-time employment.

• Flexible working schedule.

• Work-from-home opportunity.

• Continuous learning and development opportunities.

• Attractive career advancement prospects.