Join Our Talent Network
    Email:
    Job Area:
select
SUBMIT
Job Title:

DIRECTOR OF STATISTICS / 40 HOUR / DAY / BWH - TIMI STUDY GROUP

Job ID:
2247079
Company:
BWH
Location:
Boston-On Campus/Longwood Area
Department:
Std Hrs/Wk:
40.00
Shift:
Day
Full/Part Time:
Full-Time
Regular/Temporary:
Regular
Apply Now
Responsibilities

GENERAL SUMMARY/ OVERVIEW STATEMENT:

Leading the Biostatistics department, this position is responsible for oversight of all statistical analyses from assigned TIMI trials. The TIMI Study Group is an academic research organization that has led multiple large-scale, international randomized controlled clinical trials in cardiovascular medicine for over 20 years. The Director of Statistics, using a comprehensive understanding of biostatics with particular expertise in design and analysis of clinical trial data, will collaborate closely with Physician Investigators to determine the proper statistical plan and analyses and plan the statistical work flow of each trial.  Additionally, the position is responsible for staff resourcing, achieving departmental objectives, and implementing plans for further improvement of departmental operational processes.


PRINCIPAL DUTIES AND RESPONSIBILITIES:

1. Possess a solid understanding of the purpose, objectives and goals of each trial. 
2. Collaborates with Physician Investigators to develop statistical plans for investigational protocols and in the preparation of manuscripts,  abstracts, and presentations at scientific meetings.
3. Directs and ensures the accuracy and timeliness of each analysis request. Anticipate and communicate quality issues that may impact deliverables or  timelines and propose and implement solutions.
4. Ensures adequate staffing resources to meet departmental objectives, through recruiting, selecting, orientating, training, assigning, scheduling,  coaching, counseling and disciplining employees; communicates job expectations, planning, monitoring, appraising, and reviewing job contributions,  planning and enforcing policies and procedures of Biostatisticians.
5. Assures the maintenance of an up to date binder for all trials recording all data requests and data transmissions performed.
6. Manipulates or oversees the manipulation of datasets across a variety of statistical software formats to allow for integration and pooling across  trials. 
7. Oversees the compilation and organization of data for transmission to Investigators, Sponsors, and Director of Operations.   
8. Develops novel ways to coordinate, manage and report data for new trials. 
9. Represents Biostatistics in meetings with cross functional project teams (internally) and regulatory agencies (externally).
10. Ensures adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements by contributing to SOP development and training.   
11. Performs other duties as required and as appropriate. 

 

Requirements

QUALIFICATIONS:

1. Masters degree in Biostatistics, Statistics, Public Health or related field required with 7 to 10 years pharmaceutical or biomedical industry  experience, including work with clinical trials data

OR

1. PhD and 5 years of post PhD pharmaceutical or biomedical industry experience, including work with clinical trials data

2. Proficiency in SAS and STATA (proficiency in other statistics packages a plus)
3. Previous supervisory experience 


SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

1. Ability to accept a high degree of authority and responsibility for major decision-making as it relates to the statistical conduct of large domestic  and international clinical trials.
2. Excellent judgment and ability to interpret statistical information and protocol requirements, and initiate appropriate actions given competing  priorities.
3. Outstanding interpersonal and leadership skills to effectively interact with Physician Investigators, and to represent TIMI Study Group to Sponsors  and Regulatory Authorities (domestic and international).  
4. Fluency in English with outstanding written and oral communication skills to work with individuals from various fields of expertise and with  participants from various backgrounds, and to function effectively as a member of a research team.
5. Outstanding organizational abilities to formulate and complete rigorous timetables.
6. Ability to travel nationally and internationally on short notice.
7. Demonstrated Project Management skills.
8. Biostatical experience required but not limited to include; sample size determinations; superiority, non-inferiority, and closed testing procedure  designs; efficacy and futility stopping rules and spending functions; survival analysis; analysis of array data; dimension reduction techniques;  permutation testing; and repeated measurements


WORKING CONDITIONS:

Busy office environment with frequent deadlines


SUPERVISORY RESPONSIBILITIES:

Oversight responsibility for 8+ Biostatisticians within the TIMI Study Group

 

 

 

Shift

Day Shift

EEO Statement

An EEO, AA, VEVRAA Employer

Apply Now

CONTACT US  |   DISCLAIMER  |   DIRECTIONS  |   GIVING  |   PRIVACY  |   SITE MAP

As an equal opportunity employer, Brigham & Women's Hospital is also committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact Human Resources at (617) 582-0100.