Theorem Clinical Research(56 Positions in home-office location, US)

Example Job:

Theorem Clinical Research is seeking Statisticians for full-time, salaried roles in the US. In this role, the selected candidate will analyze all parts of any clinical study, and provide planning on multiple clinical studies from multiple clients, along with the following:

Manage Biometrics project teams and track department project activities (including project revenue) and provide status updates.

Prepare statistical sections of protocols, including sample size calculations; develop randomization specifications and verify

Represent department on interdepartmental project team and serve as contact with clients for statistical aspects of clinical studies. May serve as project leader for “back-end” projects involving multiple studies.

Assist in establishing departmental processes, interaction with other departments, training of staff and other departmental administrative duties.

Planet Pharma (40 Positions in Bridgewater, NJ)

Example Job:

The EBM biostatistician provides statistical expertise for all observational research project sponsored by the Sanofi US Evidence Based Medicine (EBM) in protocol development, Statistical Analysis Plan (SAP) preparation and study report. The role needs to ensure that appropriateness of study design, sample size and statistical methodologies are used and adherence to the established standards and SOPs. The role manages the timely execution of statistical and research methodological components of EBM study protocols in order to meet project objectives and has a thorough understanding of current requirements for statistical standards.

Johnson & Johnson (36 Positions in Spring House, PA)

Example Job:

Janssen Research & Development, LLC., a Johnson and Johnson Company is recruiting for a data scientist in the Biologics Clinical Pharmacology (BCP) department located in Spring House, PA. The position is expected to play a leading role to ensure data flow and integrity by supporting non-clinical and clinical studies across all therapeutic areas from early discovery through post-approval. The data scientist is expected to work closely with IT and the BCP scientists to maintain the department’s Pharmacokinetics and Pharmacodynamics data repository. In addition, the position will interface with colleagues in BCP Compliance, Data Management, Data Analysis and Reporting, Quantitative Sciences, Clinical Team, Biologics Toxicology and Quality Assurance to mitigate the complexities of data flow, maintain/improve data integrity and help implement changes needed to increase efficiency and accuracy of BCP studies and systems.

Genentech (33 Positions in South San Francisco, California)

Example Job:

Like other team members in Biostatistics, you will be responsible for the statistical integrity, adequacy and accuracy of RWD analyses, investigations, and system assessments. As such, you will collaborate with other statisticians and multifunctional working teams and may also lead Biostatistics teams. Given the nature of their positions, statistical scientists also work closely with their Biostatistics counterparts on the US Medical Affairs medical teams, Pharmaceutical Development, Global Medical Affairs, Pharmaceutical Research and Early Development, and potentially Commercial to align RWD and statistics across varying drug development phases.You will be expected to perform your responsibilities with increased expertise and independence.

Where assigned, you will also act as Medical Affairs representatives in related review and decision-making forums or committees, including, where applicable, representing Biostatistics input and data in health authority meetings, presentations and communications.All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business.

Fred Hutchinson Cancer Research Center (32 Positions in Seattle, WA)

Example Job:

This position will work closely with a PI and research team from CRD on studies focused on chronic graft-versus-host disease (GVHD) and long-term follow-up research after HCT. Responsibilities will include study design, creation of data-cleaning programs, primary and secondary analyses of clinical, epidemiological, and high-dimensional molecular data, and sample identification from the biorepository based on clinical characteristics. Participating centers are located in the US and Canada, and studies are funded by NIH. This position will also involve collaboration with studies conducted by the breast cancer group within the CRD and FHCRC/UW Consortium, providing analyses of clinical and high-dimensional molecular data. The successful candidate will be supervised and supported by the faculty and programming staff within Clinical Biostatistics, but will be expected to be able to work independently, grasp the biologic fundamentals of the target diseases, and enjoy being a key member of a very active research consortium.

Clinical Solutions Group (25 Positions in King of Prussia, PA)

Example Job:

Global leader in Clinical Research is seeking Statisticians for full-time, salaried roles in the US. In this role, the selected candidate will analyze all parts of any clinical study, and provide planning on multiple clinical studies from multiple clients, along with the following:

Review ISS/ISE statistical analysis plan; prepare patient evaluability listings; review protocol and CRF, data management plan and edit specifications; request and perform breaking of blind procedure; review interim and statistical analysis plan.

Prepare and review data display and annotation of safety and efficacy shell data displays; perform quality control of complex safety, efficacy, ISS, ISE data displays as well as data integration.

Provide specifications and review for structure, content and algorithms for ADaM efficacy datasets.

Prepare statistical report and statistical section of CSR; prepare charter for DSMB/DMC.

Understanding of ICH Guidelines E3, E9, E10

Gilead (22 Positions in Foster City, CA)

Example Job:

Works collaboratively with Biomarker Scientists, Bioinformatics, Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting. Works concurrently on 3-4 assigned components of a clinical trial / project as well as other tasks as assigned by supervisor. Excellent verbal and written communication skills and interpersonal skills are required. Demonstrates sound judgment in determining whether a situation calls for negotiation or problem solving. Reacts quickly and proactively to accommodate business need (e.g., ability to transition rapidly between projects).

Abbvie (19 Positions in North Chicago, IL)

Example Job:

Statistics is responsible for providing services in the area of biostatistics and mathematics to all corporate divisions. These services are supplied in the context of a cooperative, project-oriented effort and included statistical planning and scientific input in general planning and execution of clinical trials, pre-clinical trials and other experiments as well as integration of all scientific expertise and available technologies to provide statistical analysis of the data from these trials. These services also include the generation of scientific reports summarizing the trial or experimental results for communication to regulatory agencies and scientific audiences. We have an exciting opportunity for an Assistant Director, Statistics or Senior Manager, Statistics based in North Chicago, IL.

Intercept Pharmaceuticals (18 Positions in San Diego, CA)

Example Job:

Accountable directly or through subordinates for the statistical strategy and design in all projects. Provides input to abstracts and manuscripts to ensure that statistical elements are in line with the overall product strategy. Additional essential functions of this position include: ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements by contributing to SOP development and training; leading in the development and adaptation of new statistical methodology in support of drug research and development as required; keeping current with regulatory guidance and requirements in the global environment; hiring, mentoring and managing employees to maintain a competent and qualified staff; selecting and hiring qualified and cost-effective CRO’s to supplement internal resources; and monitoring the performance of CRO’s to ensure high quality products and services.

Merck & Co. (17 Positions in Boston, MA)

Example Job:

As a postdoctoral fellow in Precision Medicine and Genetic Capabilities you will work on Microbiome research with a highly collaborative team of scientists from Immunology, Translational Medicine, Discovery and Clinical Pharmacogenomics, and Informatics to design, plan and implement advanced techniques in microbiome sequencing and analysis. This postdoctoral opportunity provides an opportunity to work on leading edge research that is expected to have an impact in our understanding of disease pathobiology, host-microbe and microbe-microbe interactions and patient care. We are seeking a talented genomics scientist who is keen to pursue microbiome research that will have an emphasis on novel discoveries, a potential for patient impact and will generate high impact publications.