Senior Clinical Data Scientist

BioCT Innovation Commons; Ridgefield (CT); Remote; USD 100,000 - 130,000; Full time

Job summary

A leading company seeks a Senior Clinical Data Scientist to transform and analyze data from clinical trials and real-world studies. The ideal candidate will have extensive experience in statistical methodologies and clinical trial design, and will support complex projects while interacting with various departments and stakeholders. This role offers the flexibility of telecommuting and requires travel for project needs.

Qualifications

• 3 years of experience with a Master's or 5 years with a Bachelor's in relevant fields.
• Experience in statistical methodology and data processing.

Responsibilities

• Transforming, analyzing, and reporting on phase I-IV clinical trials.
• Ensuring data specifications meet guidelines and GxP requirements.
• Supporting cross-functional teams and representing BI in regulatory issues.

Skills

Statistical methodology

Clinical trial design

Regression analysis

Survival analysis

Multivariate analysis

Hypothesis testing

SAS

R

Python

Education

Master's degree in Statistics, Applied Mathematics, Computer Science, or related field

Bachelor's degree in Statistics, Applied Mathematics, Computer Science, or related field

Job description

Description

POSITION ELIGIBLE FOR BENEFITS UNDER EMPLOYEE REFERRAL PROGRAM

Employer: Boehringer Ingelheim Pharmaceuticals, Inc.
Job Title: Senior Clinical Data Scientist
Location: 900 Ridgebury Road, Ridgefield, CT 06877 (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 BI experience. Accountable for transforming, analyzing and reporting of 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 BI. Present compelling validated stories regarding data science aspects to Biostatistics and Data Sciences (BDS) colleagues and colleagues within and outside BI 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 BI. Know, understand, and implement: (i) international regulations and guidelines for good clinical and statistical practice from all International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regions, (ii) the various international guidelines on clinical development, including statistical methodology, for Therapeutic Area (TA)-related disease areas, and (iii) BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g., Clinical Development Plan). Solve complex, defined problems with operational / limited strategical impact within clinical research and development, taking into account needs and requirements of other units and departments. Interact with various other functions and roles within and outside BDS contributing to and/or having operational impact regarding substance level, including colleagues from Global Clinical Operations (GCO), Global Pharmacovigilance (GPV), TAs, Translational Medicine and Clinical Pharmacology (TMCP), and Global Regulatory Affairs (GRA). Represent BI for regulatory issues and requests around planning, analyses and data transformation regarding the trial/project/asset. *Telecommuting permitted: work may be performed in any location in the U.S.

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

Description (cont'd)

Job Requirements: Master's degree (U.S. or foreign equivalent) in Statistics, Applied 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, Applied 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: statistical methodology, design of clinical trials or clinical experiments, basic medical terminology, and processing of clinical trial information; advanced statistical concepts related to Data Science, including regression analysis, survival analysis, multivariate analysis, and hypothesis testing; using software language, including SAS, R, or Python; leading and facilitating meetings; working in global and remote teams; identifying, as well as interacting with internal and external stakeholders on, routine data science issues and solutions; and, working with the pharmaceutical industry, Contract Research Organizations, regulatory authorities, or academic institutions. 20% domestic and international travel required.