Sr. Biostatistician

Sr. Biostatistician
Duration: 6+ Months
Location: REMOTE. The candidate must be on the east coast.

Sr. Biostatistician
Functions independently as a project lead or lead statistician to deliver the project tasks/responsibilities. Performs project management functions relating to the administrative and scientific activities of specific project work and team members. Oversees statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians.
Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.
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.

Education and Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years ).

• Master's degree in statistics, biostatistics, mathematics or related field
  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 understandingof 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 departments

Manager Notes:

1. Experience in working in Sponsor organization ( Pharma and Biotech work experience)
   2. Strong Lead stat experience worked as Study or compound lead for good number of years and worked as Stat rep in the cross functional team
   3. Strong Statistical knowledge and updated on regulatory requirements
   4. Very good communication skills and expressive skills.
   5. Ph.D would be a plus but definitely MS in Biostatistics ( not preferring analytic statistics or mathematics or MPH type qualifications).