Software Engineer

• Mastery and trained on generating tables, listings, and graphs from clinical trial databases using SAS.
• Utilizes System Development Life Cycle (SDLC) for programming deliverables.
• Advanced user in SAS programming, SAS Base, and SAS Macros.
• Advanced knowledge of E-Submission Standards, Guidelines and Regulations.
• Mastery and trained on SDTM standards including ability to write specifications.
• Advanced knowledge of ADaM standards including supporting specification writing.
• Proficient with MS Office applications.
• Advanced knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements.
• Advanced experience with pooling of data sets for submissions.
• Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP.
• Lead study or small programming project teams.

Senior Statistical Programmer

Proposal Manager

• Interpret and assess requests for proposal (RFPs) or requests for information (RFIs) and build a response that addresses Sponsor requirements and provides a compelling message differentiating our offering.
• Coordinate with Business Development Leads and subject matter experts throughout the company to build an operational strategy to address the Sponsor’s needs.
• Coordinate with SMEs to provide responses to Sponsor-specific questions and concerns.
• Collect specifications and details from SMEs and build a budget that clearly outlines the appropriate deliverables, pricing, resourcing and timelines.
• Support the defense of proposals and pricing to Sponsors as well as to internal approvers.
• Continuously improve the process of developing proposals and budgets, incorporating technology where appropriate, to more efficiently provide deliverables, check for quality gaps, and effectively manage communication.
• Support the maintenance of internal proposal and response libraries.

Senior Proposal Development Manager

Compliance

• Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates
• Understanding of how to plan, prepare and conduct GxP audits independently
• Ability to support clients with development or refinement of Quality Management Processes or Systems
• Project management as it relates to quality and compliance activities
• Proficient in authoring and managing audit documents independently
• Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently
• Assists in other duties relating to overall compliance within Quality and Compliance department, as requested
• Must be willing to travel up to 30% of the time for audits within the US; must also be willing to travel internationally as needed

Senior Quality and Compliance Specialist

Designer

• Assisting customers with their study design with a particular focus on simulation with KerusCloud to ensure they are aligned with the study objectives.
• Preparation of study protocols and development of Statistical Analysis Plans and Statistical Analysis Reports.
• Summarize, analyze and visualize study data using a variety of statistical methods, ultimately delivering results to an agreed timeline with optimal quality.
• Provide statistical consultancy support to sponsors across the full span of clinical development, including oversight of third-party statistical and programming deliverables.
• Maintain current knowledge of relevant research techniques such as modelling, simulation and experimental design and participate in continuous professional development activity.
• Support pre-sales discussions to understand and identify client needs, then contribute to technical solutions and resource/ cost estimates.
• Collaborate with the Product Development team defining key features and statistical aspects of KerusCloud.
• Provide input and support to Marketing of KerusCloud, including demonstrations to clients, white papers, etc.

Study Design Statistician

Clinical Research

• Lead complex projects, programs, and submissions
• Manage client meetings, CRMs, collaborate well with regulatory, PMs, and sponsors
• Develop SAPs and iSAPs text and shells with no supervision
• Produce and present external company presentations providing industry visibility
• Suggest solutions to solve issues in tune with organizational direction
• Review or develop ADAM specifications; work with programmers and junior statisticians to resolve comments
• Apply drug development knowledge during the production of complex statistical analyses
• Review or create the statistical section(s) of a Sponsor’s protocol and ensure appropriate statistical methods are proposed
• Provide valuable feedback to the Sponsor on the statistical aspects of the study
• Prepare and review statistical methods and results sections for the CSR independently
• Demonstrate an understanding of project management-related tasks such as timelines, scope and resource management
• Perform sample size calculations for various scenarios and study designs
• Provide statistical consulting support to sponsors regarding study design and sample size calculations
• Create randomization and kit schedules independently
• Collaborate with sponsors, randomization, and drug supply management teams
• Support Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician
• Stay current with the latest industry practices and regulatory guidelines
• Write blogs and/or white papers for posting on the company website

Principal Biostatistician

Content Writer

• Critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, Informed Consent Forms and Clinical Protocols
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Interact directly and independently with client to coordinate all facets of projects; competent communication skills for projects
• Contribute substantially to, or manages, production of interpretive guides
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process

Senior ICF Writer

Medical writer

• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
• Contribute substantially to, or manages, production of interpretive guides
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process

MMS