Senior Statistical Programmer

About the Company

VALOS is an international, specialized CRO headquartered in Genoa, Italy, www.valos.it, 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

Skills Required
Sas Base, Gcp, Sdtm, Ich, ADAM