Senior Statistical Programmer

Innovaderm Research Inc.

. Lead single and/or multiple clinical trials as Lead Statistical Programmer .

Posted 9/15/2026full-timeRemote • PhilippinesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in leading clinical trials and statistical programming, with a strong focus on developing and validating SDTM and ADaM datasets, ensuring compliance with regulatory standards, and mentoring junior team members. Proficient in SAS programming and familiar with CDISC standards and guidelines.

Highest-signal resume keywords

Lead Statistical Programmer ExperienceSAS Programming ProficiencyCDISC Standards KnowledgeClinical Research ExperienceStatistical Programming Expertise

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Statistical ProgrammingSDTM Dataset DevelopmentADaM Dataset DevelopmentCase Report Form ValidationStatistical Analysis Plan ReviewXML ProgrammingData CleaningPinnacle 21 ValidationSubmission Package PreparationStatistical Data Issue Resolution

Soft Skills

Project PlanningTime ManagementTeam CollaborationEffective CommunicationDetail-Oriented

Tools & Technologies

SASPinnacle 21Statistical Analysis PlansTLF ShellsECRFs

Certifications & Qualifications

SAS CertificationCDISC Certification

Industry Keywords

Clinical TrialsBiotechnologyPharmaceutical IndustryContract Research OrganizationICH GuidelinesHealth Canada RegulationsFDA RegulationsElectronic Data SubmissionDrug Development ProcessGPP Standards

About the role

Key responsibilities & impact

Lead single and/or multiple clinical trials as Lead Statistical Programmer
Develop, maintain, and validate annotated Case Report Forms (aCRFs)
Develop, maintain, and validate specifications and statistical programming for SDTM datasets, ADaM datasets or derived datasets, Tables, Listings, and Figures (TLFs)
Prepare submission packages for DMC data review meetings, Interim Analyses, and Clinical Study Reports
Review and provide input into Statistical Analysis Plans, TLF Shells, eCRFs, edit checks, and other Data Management documents
Support data cleaning by programming, reporting, reviewing, and closing statistical data issues
Develop and validate SDTM and ADaM define.XML/.PDF files and reviewer guides
Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21
Use global SAS macros to improve programming efficiency
Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and Interim Analyses
Contribute to and participate in internal initiatives involving standard macros, templates, programming standards, and processes
Collaborate with Biostatistical study teams and other departments to deliver high-quality work within timelines and budget
Ensure compliance with ICH guidelines, pharmaceutical industry standards, regulatory requirements, and company SOPs
Keep current with industry, CDISC, ICH, and regulatory standards
Mentor more junior Statistical Programmers as needed

Requirements

What you’ll need

Bachelor’s degree in Statistics, Computing Sciences or a related field; master’s degree an asset
At least 5 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry
At least 4 years of Statistical Programming experience
At least 1 year acting as a Lead Statistical Programmer
Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications
Excellent working knowledge of SAS; SAS certification an asset
Knowledge of XML programming an asset
Excellent working knowledge of CDISC standards and guidelines; CDISC certification an asset
Excellent knowledge of drug development process, ICH guidelines, relevant Health Canada and FDA regulations, guidelines, electronic data submission requirements, and Pharmaceutical Industry GPP
Very organized and detail-oriented, with effective project planning and time management skills
Ability to work in a high-speed environment and prioritize multiple competing demands
Ability to work independently and as part of a team
Strong verbal and written communication skills in English; French an asset
Must be legally able to work in the Philippines

Benefits

Comp & perks

Permanent full-time position
Flexible schedule
Home-based position
Ongoing learning and development
Attractive advancement opportunities