Senior Statistical Programmer

About the Company

VALOS is an international, specialized CRO headquartered in Genoa, Italy, , recognized for its excellence in Biostatistics and Data Management. We partner with leading pharmaceutical and biotech companies worldwide, delivering high-quality statistical solutions that drive clinical research forward.

About the Role

We are looking for talented Senior Statistical Programmer with at least 5 years of experience to join our growing Biostatistics Department in India.

Responsibilities

• Create ADAM and TFLs for clinical studies
• Apply advanced statistical methodologies to clinical trials and RWE studies
• Contribute to the development of Statistical Analysis Plans (SAPs) and study reports
• Collaborate closely with cross-functional teams (data management, Statisticians, medical writing, clinical operations)

Qualifications

• Solid understanding of clinical trials across 1-4 phases, different endpoints, analysis populations, and why TFLs are produced.
• Able to work with interventional and RWD or observational data.
• Read and interpret Protocol and SAP. Translate methods and estimands into programming requirements and traceability rules. Provide programming feedback to Statisticians and align on shells.
• Build SDTM from raw sources with end-to-end traceability to CRF and EDC exports.
• Perform precise SDTM CRF annotation aligned to CDISC SDTM IG and trial design domains.
• Apply controlled terminology and clinical dictionaries (Meddra, WHODrug, etc) in SDTM mapping
• Prepare SDRG and SDTM Define.xml. Run and resolve SDTM Pinnacle 21 findings.
• Create ADaM specifications from SAP and shells with clear derivation rules and SDTM-to-ADaM traceability.
• Program ADaM across ADSL, BDS, OCCDS, and time-to-event. Produce ADaM Define.xml and ADRG. Close ADaM Pinnacle 21 findings.
• Understand and build TFL mock shells consistent with SAP and ADaM structure. Program and validate TFLs in SAS and R.
• Execute QC: independent review, double programming where applicable, internal checklists, full documentation discipline, and issue tracking to closure.
• Assemble submission-ready packages: datasets, programs, XPT, Define, ADRG, SDRG, meeting expectations of EMA, FDA, PMDA and other regulatory authorities.
• Lead or support pooled analyses and exploratory requests. Coordinate ISS and ISE datasets and outputs when required.

Required Skills

• Statistical knowledge appropriate for programmers.
• Strong SAS Base and Macro with ability to modify and maintain shared code and macros.
• Working R for data manipulation, automation, and reproducible reporting.
• Proven validation mindset and familiarity with GCP, ICH, and CDISC compliance expectations.
• Clear, concise English. Effective collaboration with Statisticians, Data Managers, Medical Writers, and Sponsor teams across time zones.
• Accountable, detail-focused, and organized. Able to plan timelines, communicate risks early, and deliver to quality and schedule in a multi-study environment.

Preferred Skills

• Experience as Statistical Programmer within a CRO or pharmaceutical company is required.

Pay range and compensation package

Why Join VALOS?

• Be part of a specialized and collaborative international team with offices in Italy, USA and East Europe
• Work on a diverse portfolio of clinical studies across therapeutic areas
• Benefit from flexible working arrangements and continuous professional development
• Contribute to high-impact research improving patient outcomes worldwide