Sr. Biostatistician(Remote)

The candidate must be on the east coast. I have attached the job description to this email.Please make sure to include a photo ID and two prior work references with work email and phone number. I WILL BE CHECKING!!!!

1. Experience in working in Sponsor organization ( Pharma and Biotech work experience)
2. Strong Lead stat experience worked as Study or compound lead for a 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).

6. The end client is looking for someone with Sponsor experience NOT IN A CONTRACT ROLE!!!

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).

Himanshu Goswami

Sr. IT Technical Recruiter

Stellent IT Phone:

Email: Himanshu.goswami
Gtalk: Himanshu.goswamiom