Biostatistician II- fully remote!

Thermo Fisher Scientific•Morrisville, NC

4d•Remote

About The Position

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. The Biostatistician II will work under the guidance of a Biostatistical Team Lead to implement statistical analysis plans involving complex longitudinal registry data available in several autoimmune disease areas. This individual will help to prepare appropriate analytic summaries and context for reports and publications. The CorEvitas Biostatistics team at Thermo Fisher Scientific is comprised of three key focus areas: query work, pharmacovigilance, and registry coordination. With query work we design, analyze, and report on research projects, i.e. queries, with our clients to produce publications for the public domain (e.g. abstracts, posters, podium presentations, manuscripts, etc.) For our pharmacovigilance work we design studies, analyze data, and develop reports to provide real-world evidence regarding drug safety. We partner with our pharma clients to conduct long-term post-authorization safety studies to support FDA, EMA, or other regulatory commitments. Within our registry coordination team, we work cross-functionally with the Engineering, Clinical Data Management, and Project Management teams on all registry data, while incorporating client requests from the query and PV work. Registry team information: The Registry team plays a central role in registry design, analytic file and report development, content consultation, data management, and overall registry operations’ maintenance. For new registries, this work involves consulting with subject matter experts, identifying key data elements, writing code to create analytic datasets, reviewing dataset specifications, and ensuring outputs are quality controlled and aligned with defined requirements. For existing registries, the team updates and maintains code to support evolving registry needs including ongoing improvements and mid-study updates (MSUs). This work is conducted cross-functionally with the Engineering, Clinical Data Management and Project Management teams on all the registry data taking into account client requests from our query and PV work.

Requirements

Master's degree in Biostatistics, Statistics, Bioinformatics, Mathematics or related field is required. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Experience equivalent to 3 years of applied statistical is required.
Experience with data manipulation and transformation of large complex longitudinal datasets to support statistical analyses is required.
Extensive knowledge of programming using R is required.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

Experience with data science techniques including machine learning and associated software is a plus.
Experience with GitHub for reproducibility, version control and collaboration is preferred.
Must be highly organized and detailed-oriented with excellent time management skills and ability to prioritize tasks.
Must possess strong communication skills and be able to work independently and as part of a team.
Requires clear writing skills and must follow best practices for commenting of programming code.

Responsibilities

Writes, reviews, tests, and maintains code to support analytic dataset development and statistical analyses, ensuring accuracy, efficiency, and reproducibility.
Implements data quality initiatives under the guidance of the Registry Lead to ensure accuracy, completeness, and reliability of datasets.
Works closely with the Registry Lead to ensure timely completion of deliverables and adherence to project deadlines.
Assists the Registry Lead in maintaining existing reports and developing new reports as needed.
Produces monthly analytic data cuts, monthly reports, and quarterly reports, ensuring accuracy, consistency, and alignment with reporting requirements.
Serves as an additional point of contact for assigned registries, proactively supporting colleagues by addressing registry-related questions on data structures, outputs, etc.
Provides support on ad hoc projects and analyses as needed.
Creates data pipelines for ingestion of external data sources and integration with clinical registry data to create combined datasets.
Compiles, analyzes and reports statistical data for various projects.
Carries out complex statistical analyses with supervision according to a statistical analysis plan.
Assists Biostatistical Team Lead in the development of new statistical methodology for measurement and analysis of data.
Assesses relevant literature as well as existing data, evaluates the quality of data used in reports and assists with preparation and distribution of periodic reports.
Prepares written reports and summarizes data for investigators with minimal supervision.
Makes original contributions to research projects, takes initiative in professional activities and beginning to be more independent in their statistical decision making.
Closely collaborates and participates in knowledge sharing with other statistical analysts.