Biostatistician Ii

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).

PPD clinical research services’ mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

We are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight.

As a Biostatistician II within our **Early Phase **team, you will function independently as a project lead or lead statistician on select projects to deliver the project tasks/responsibilities. As well you will perform project management functions relating to the administrative and scientific activities of specific project work and team members.

**Essential Functions**:

- Ensures compliance with the activities outlined in the department's Working Practice Documents and contributes changes as needed. Follows departmental procedures for statistical analyses and programming work.
- Work independently as a project lead or as lead statistician to deliver on lead tasks/responsibilities across large and complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.
- Provides sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Provides randomization schemes and appropriate documentation.
- Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis.
- Provides specifications for analysis database, oversee its development, and assures completeness for use in all programming. Coordinates with programmers and data management personnel as to database maintenance, updating, and documentation. Performs statistical analysis for key efficacy endpoints.
- Prepares reports, manuscripts, and other documents. Contributes statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.
- Monitors project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management.
- Mentors members of the department by providing project guidance and statistical advice and by promoting employee development, completing performance planning, and providing resource planning.
- Provides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires).
- Acts as the representative of the department to other divisions. Assists in bidding and business development activities. Consults with business development with respect to bids and timelines.
- Master's degree in statistics, biostatistics, mathematics or related field.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).

**Knowledge, Skills and Abilities**:

- Strong SAS® programming skills
- (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures
- Capable of directing and promoting teamwork in a multi-disciplinary team setting
- Strong understanding of statistical principles and strong statistical skills
- Solid project management skills, as shown through management of multiple projects
- Demonstrated initiative and motivation
- Strong written and verbal communications skills, including proficiency in the English language
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long
- range planning, adapt to changing priorities and handle multiple projects
- Strong interpersonal skills and positive attitude to work effectively in a team environment and act as a liaison with other department.

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that yo