Senior Director, Biostatistics - Remote

Biostatistics United States


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

 We’re looking for an exceptional Senior Director of Biostatistics to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

 At Premier Research, we are science-minded and heart-centered. Join us.

The Senior Director of Biostatistics serves as a core team member and leader for larger projects. He/she is responsible for Biostatistical operations, directing project assignments, and the overall activities of project team personnel. The Senior Director reviews departmental deliverables for accuracy, completeness, and compliance with project specifications to ensure quality deliverables to Sponsors. In addition, he/she is responsible for both management and technical aspects of development projects, and, as a technical expert, provides strategic guidance to development projects, with particular emphasis on scientific rigor and application of ‘current’ statistical methodology. When functioning in a supervisory role, the Senior Director provides coaching and guidance to more junior staff and line management to the team, while overseeing the technical evolution of the departmental work product. Additionally, the Senior Director contributes at least 60% of their time to Biostatistics project work as the Principal Biostatistician level of technical expertise and experience. Also, this individual represents the department during bid meetings, audits, and to provides line management and statistical advice throughout clinical projects. The Senior Director ensures that project teams adhere to Premier Research's Standard Operating Procedures and project-specific guidelines.
  • Prepares specifications for CDISC and other analysis data sets
  • Independently develops statistical analysis plans
  • Acts as Lead Biostatistician to interact with the study team and the Sponsor
  • Supports Business Development by preparing for and attending bid defense meetings, preparing capabilities presentations, and assisting with budget and proposal development.
  • Acts as an independent Biostatistician on DSMBs and DMCs
  • Acts as Project Manager for one Biostatistics stand-alone project, and completes consultancy work as needed
  • Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop the team structure
  • Directs efforts in Biostatistics project costing estimates and change order process
  • Provides oversight and reporting of project progress and financial health within Biostatistics
  • Integrates operations between Biostatistics and other departments to obtain increased productivity, efficiency and quality

RESPONSIBILITIES:

For project success:

  • Independently develops SAS programs to generate listings, tables and figures as outlined by a statistical analysis plan and to generate randomization codes
  • Performs QC of TLFs, CDISC and other analysis data sets
  • Develops and maintains overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
  • Keeps detailed records of time spent on each project to allow accurate billing
  • Respects and maintains the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
  • Maintains Biostatistical section of TMF
  • Reviews and provides feedback on Data Management documents
  • Reviews study protocols
  • Provides statistical input to Clinical Trial Reports
  • Facilitates resolution of project related conflicts with necessary corrective action and alerts senior management to potential issues
  • Develops strong relationships with current clients to generate new and/or add-on business for the future

    For commercial success:

  • Ensures work completed is completed is on time at the correct level of quality
  • Builds strong relationships with Data Management to provide proactive support
  • Tracks project revenue and backlog
  • Tracks hours by keeping detailed records of hours worked on projects for accurate billing and to forecast hours to complete
  • Ensures that audits have appropriate Biostatistics representation and participates as necessary
  • Participates in and contributes to the training and development of new staff
  • Leads efforts in the development, maintenance and adherence to departmental SOPs and guidelines
  • Strategic responsibility for all staffing and operational aspects of the allocated Biostatistics group

    Other

  • Participates in efforts for efficiency and productivity in the department
  • Attends project team and other company meetings, as required
  • Assigns project work to staff
  • Participates in functional and/or corporate initiatives, including committees, special assignments, and acts as the departmental cross-functional liaison
  • Develops and implements strategies to actualize goals
  • Performs other work-related duties as assigned
You'll Need:

  • Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field
  • 8– 10 years of experience in clinical trials design and analysis using SAS
  • 4 – 6 years of experience as supervisor/manager
  • Prior experience using computerized information systems preferred.
  • Ability to read, write, and speak fluent English; fluent in host country language.
  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
  • Works with internal and external customers/vendors to meet project specific goals. 
  • Identifies, monitors, documents, and tracks out-of-scope activities.
  • Demonstrated experience in interactions with regulatory agencies (e.g., FDA, EMA, EU member states, etc.)
  • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook Evidence of good SAS programming skills
  • Knowledge of web based communication tools for conferences
  • Evidence of advanced SAS programming skills
  • Applies clear and consistent performance standards and handles problems decisively and objectively
  • Fluent verbal, written, and interpersonal English as well as the local language(s) required for clinical trial submissions.
  • Excellent team player, collaborative and able to build an effective team.
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities.
  • Strong verbal and written communication and negotiation skills.
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines.
  • Accountable, dependable and strong commitment. 
  • Is customer service focused in approach to work both internally and externally.
  • Maintains a positive, results orientated work environment.
  • Ability to build client confidence and achieving high levels of customer satisfaction
  • Ability to communicate basic statistical concepts to other scientists and nonscientists
  • Ability to motivate and lead a team of varying levels of status and ability
  • Proactive management skills 
  • Cross cultural awareness
  • A willingness to travel, ~20%
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