Principal Analyst, Statistical Programming

Scorpion Therapeutics; San Francisco Caballúa; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A biotechnology company located in Mexico, Oaxaca seeks a Principal Analyst for Statistical Programming. The ideal candidate will lead statistical programming activities, manage high-quality data analyses, and oversee the delivery of key project deliverables. A minimum of 7 years' experience in SAS programming, data management, and clinical trials within the pharmaceutical or biotech field is essential. This role requires strong attention to detail and leadership skills in a collaborative environment.

Formación

• 7+ years relevant work experience with a focus on data management and analysis.
• 7+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO.
• 7+ years relevant pharmaceutical/biotech industry experience.
• 7+ years clinical trial experience.
• 5+ years clinical database experience.
• CDISC and/or submissions experience.
• Familiarity with UNIX.

Responsabilidades

• Leads and oversees statistical programming activities for projects.
• Authors CDISC ADaM analysis dataset specifications.
• Manages end-to-end programming of deliverables from CRF collections.
• Identifies process inefficiencies and leads efforts to remedy them.
• Serves as Statistical Programming Lead to achieve study milestones.

Conocimientos

SAS Base programming

Data management and analysis

Attention to detail

Management skills

Knowledge of drug development process

Knowledge of clinical trials

Herramientas

SAS STAT

SAS GRAPH

R

Descripción del empleo

Role Summary

The Principal Analyst, Statistical Programming reports to the Associate Director of Statistical Programming at Biogen West Coast Hub. Leads and oversees statistical programming activities for projects managed internally and via external vendors, applying data standards and producing analysis datasets, dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. Partners with Biostatistics to deliver high-quality, submission-ready statistical outputs.

Responsibilities

• Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via internal and/or external staff oversight.
• Authors CDISC ADaM (analysis data model) analysis dataset specifications, identifying potential data issues; collaborates with statistics on defining and documenting programming endpoint algorithms.
• Manages end-to-end programming of deliverables from CRF collections through electronic submission, including preparation of ESUB components (input to reviewer’s guides, annotated CRF, define and XPTs), and ensures compliance to eSUB standards with SMEs.
• Identifies process inefficiencies and leads efforts to remedy them and train the department on new processes.
• Serves as Statistical Programming Lead to achieve study milestones; evaluates task objectives and collaborates with PL and/or manager on issues or resource needs.
• Verifies program consistency and usage of data, analysis and submission standards across the department in consultation with data standards, statistical submissions management, and the data strategy plan.
• Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.

Qualifications

• Required: 7+ years relevant work experience with a focus on data management and analysis
• Required: 7+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO
• Required: 7+ years relevant pharmaceutical/biotech industry experience
• Required: 7+ years clinical trial experience
• Required: 5+ years clinical database experience
• Required: CDISC and/or submissions experience
• Required: Knowledge of drug development process and clinical trials
• Required: Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
• Required: Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
• Required: Management skills and ability to lead and collaborate across functions
• Required: Attention to detail with the ability to manage competing priorities
• Preferred: Experience with ISS/ISE and NDA/BLA submission
• Preferred: R Programming skill