Senior Clinical Data Scientist

BioCT Innovation Commons; Connecticut; Remote; USD 80,000 - 120,000; Full time

Job summary

Join a forward-thinking company as a Senior Clinical Data Scientist, where you'll transform and analyze data from clinical trials, contributing to innovative research. In this role, you will work closely with cross-functional teams to ensure data integrity and compliance with industry standards. Your expertise in SAS and R will be crucial in generating CDISC-compliant datasets and statistical reports. This position offers the opportunity to make a significant impact in the pharmaceutical industry while collaborating with talented professionals. If you're passionate about data science and eager to drive advancements in clinical research, this is the perfect role for you.

Qualifications

• Experience in pharmaceutical industry or with CROs, regulatory authorities.
• Proficient in SAS and R for data analysis and reporting.

Responsibilities

• Transform, analyze, and report data from clinical trials.
• Lead cross-functional teams and ensure compliance with guidelines.

Skills

SAS

R

Data Science Principles

Statistical Methodology

Clinical Trial Development

Project Leadership

Data Transformation

Survival Analysis

Basic Medical Terminology

Education

Master's degree in Statistics or related field

Bachelor's degree in Statistics or related field

Tools

SAS/BASE

SAS/MACRO

SAS/GRAPH

SAS/STAT

SAS/SQL

Job description

Senior Clinical Data Scientist at Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT (Telecommuting permitted: work may be performed in any location in the U.S.)

Job Duties: Accountable for transforming, analyzing and reporting phase I-IV clinical trials and support complex phase I-IV clinical trials or projects with established Boehringer experience. Accountable for transforming, analyzing and reporting other data from research and development like registries and real-world data bases with respect to a specific use case or project/asset. Keep abreast of data science and in particular new transformation and analysis solutions and innovative processes/tools within and outside Boehringer. Present compelling validated stories regarding data science aspects to Biostatistics and Data Sciences (BDS) colleagues and colleagues within and outside of Boehringer with basic knowledge in data science. Ensure data transformation and analysis specifications to ensure completeness, correctness and adherence to department guidelines and SOPs as well as to applicable GxP requirements. Support other colleagues, internal and external customers and external providers on data science related tasks. Participate in cross-functional human pharma internal working-groups or lead cross-functional BDS internal working-groups and drive/plan relevant data science aspects. Ensure cross-functional and team-based working within BDS and with neighboring units at Boehringer. Contribute to and review key study documents produced by internal or other functional groups.

Work Schedule: 40 hours per week (8:00am to 5:00pm)

Job Requirements: Master's degree (U.S. or foreign equivalent) in Statistics, Biostatistics, Mathematics, Computer Science or related field and three (3) years of experience in the job offered or in a related role OR Bachelor’s degree (U.S. or foreign equivalent) in Statistics, Biostatistics, Mathematics, Computer Science or related field and five (5) years of experience in the job offered or in a related role. Must have experience with: working in pharmaceutical industry or with Contract Research Organizations (CROs), regulatory authorities, or academic institutions; using SAS or R; applying understanding of clinical trial development process; leading projects or studies; using data science principles and statistical concepts related to data science; planning, transforming, analyzing, interpreting, and reporting data in clinical trials, data across clinical trials, or data from other sources in clinical research and development; using statistical methodology, designing clinical trials or clinical experiments, using basic medical terminology, and processing clinical trial information; working on global and remote teams; proactively identifying issues and solutions and interacting with internal and external bodies on data science matters; implementing processes and standard operating procedures (SOPs) that govern clinical development; generating and validating CDISC-compliant ADaM datasets for different clinical trial phase studies; generating and validating tables, figures and listings (TFL) for different clinical trial phase studies; contributing to and reviewing statistical analysis plan (SAP) and reviewing protocols; generating ADaM programming specifications and TFL mock-ups based on SAPs and protocols; writing SAS programs using SAS/BASE, SAS/MACRO, SAS/GRAPH, SAS/STAT, and SAS/SQL to map raw clinical data to CDISC-compliant datasets and create TFL for data monitoring, clinical study report and submission for different clinical trial phase studies; reviewing case report form (CRF) design specification, edit check specifications, manual data review specifications, and vendor data transfer specifications; performing survival analysis on time-to-event data; and, implementing Laboratory Toxicity Grading for CTCAE Version 5. Up to 10% domestic travel required.