Principal Statistician / Senior Principal Statistician
US-BI Pharma/BI USA
 Ridgefield, CT

Principal Statistician / Senior Principal

Statistician

***Candidate will be

hired commensurate with the level and experience***

Description:

Perform

duties of a Trial Statistician to support complex clinical trials within

national or international development projects or for marketed products as

required. Assure well-designed clinical trials. Provide statistical

expertise necessary to design, analyze, interpret and communicate the results

of complex clinical trials. Provide statistical input for publications on

clinical trials. Either support Project Statisticians on complex projects

or act as a Project Statistician for early projects, backup projects, or

projects with established BI experience. Act as a team leader for a

complex project or mega-trial.

As

an employee of Boehringer Ingelheim, you will actively contribute to the

discovery, development and delivery of our products to our patients and

customers. Our global presence provides opportunity for all employees to

collaborate internationally, offering visibility and opportunity to directly

contribute to the companies' success. We realize that our strength and

competitive advantage lie with our people. We support our employees in a number

of ways to foster a healthy working environment, meaningful work, diversity and

inclusion, mobility, networking and work-life balance. Our competitive

compensation and benefit programs reflect Boehringer Ingelheim's high regard

for our employees.

Duties

& Responsibilities:

  • Perform
    duties of a Trial Statistician to support complex clinical trials within
    national or international development projects or for marketed products as
    required. Collaborate with members of Clinical Research and
    Marketing, Trial Clinical Monitor and trial teams incl. pharmacokineticist
    in planning clinical trials and protocols conforming to company and
    regulatory agency guidelines and/or marketing and publication strategies.
  • Act
    as Project Statistician for early projects, backup projects, or
    projects with established BI experience.
  • Support
    Project Statisticians of high profile international projects in their
    responsibilities, especially in their statistical responsibilities in the
    planning and preparation of regulatory submissions and contribute to
    efforts on cross-trial planning and harmonization.
  • Analyze
    data from phase I to IV trials incl. responsibility for program
    validation. Perform exploratory analyses in collaboration with the
    Project Statistician.
  • Prepare
    accurate, high quality reports of complex clinical trials for registration
    of drugs and biologics, publications and management.
  • Prepare
    specifications for data analyses by outside vendors as required.
    Assure compliance with the specifications by reviewing the vendors'
    products.
  • Participate
    on assigned international teams to promote harmonization efforts for
    clinical drug development.
  • Support
    management in resource planning and tracking for assigned trials and
    projects.
  • Act
    as a team leader for a complex project or mega-trial who
  • Ensures
    team members adhere to the SOPs, guidelines and local working
    instructions.
  • Attends
    all the meetings related to the trial/project needing a statistical input
    (or send delegates) and send minutes to the team members
  • Assist
    the Head of programming and Head of statistics with the working of
    vendors, contractors in establishing procedures for programming and
    validating statistical analysis (writes the scope of work, prepare
    documents to be sent to the contract research organization (CRO). From a
    statistical perspective, is the primary contact for CROs (programming validation)
  • Acts
    as a Trial or Project Statistician (TSTAT or PSTAT) for the
    trial/project. In particular, develops report and programming
    specifications in a Trial Statistical Analysis Plan (TSAP) and update this
    document as often as needed.
  • Collaborate
    with the programming group and the data management group to submit very
    detailed timelines for the trial/project to clinicians. Meeting agreed
    upon timelines are essential to the success of the clinical trial/project
    team objectives
  • From
    a statistical perspective, is the primary contact for medical writing (or
    choose a designee)
  • Ensures
    that protocol objectives are met and project standards are maintained
    (also responsible to update the project statistical analysis plan when
    necessary
  • Ensures
    achievement of major statistical deliverables and milestones in
    coordination with other functions including Clinical Research, Safety,
    Statistical Programming, Data Management and Medical Writing
  • Provides
    and organizes statistical support for regulatory meetings, questions and
    submissions.
  • Informs
    management that hours allocated to TSTAT by the capacity algorithm should
    be updated (follow up the amount of hours entered in the time recording
    system and related to the trial/project)
  • Ensures
    efficient work within the team by setting priorities and avoiding overlaps
    between team members
  • Works
    directly and proactively with the Trial, Project or Substance team.
  • Assumes
    responsibility for the coordination of all relevant statistical activities
    for a Trial, Project or Substance.
  • Receives
    broad operating instructions in performing a majority of duties from
    manager and keeps manager abreast of programming status. Alerts management
    in case of resources issues, timelines problems or conflicts within the
    team
  • In
    collaboration with the statistical expert group member, maintain expertise
    in therapeutic area, by keeping abreast of new publications with the
    purpose of increasing the overall efficiency or effectiveness in the
    department.

Principal

Biostatistician Requirements:

  • Masters’
    degree from an accredited institution required and 6 years'
    experience within the pharmaceutical industry, CROs, regulatory
    authorities, or academic institutions, or Doctoral degree (PhD, MD)
    from an accredited institution with 3 years' experience within the
    pharmaceutical industry, CROs, regulatory authorities, or academic
    institutions.
  • Ability
    to interact with authorities on statistical issues at the trial level.
  • Thorough
    knowledge of statistical methodology, processing clinical trial information
    and the drug development process.
  • Ability
    to communicate statistical information to non-statisticians.
  • Ability
    to write publications (as joint author) in clinical trials.
  • Excellent
    oral and written communication skills.
  • Ability
    to manage project from a statistical perspective.
  • Demonstrated
    ability to design, conduct and analyze a complex trial
  • Evidence
    of strong teamwork in order to successfully work with a trial team and
    project level team members

Sr

Principal Biostatistican Requirements:

  • Ph.D. in statistics, biostatistics, or biometry; at
    least 6 years’ experience in pharmaceutical clinical trial experience,
    preferably in the pharmaceutical industry and/or Regulatory Authorities,
    or M.S. in the above mentioned areas with 10 years of similar experience.
  • Ability
    to work on local/global project teams in order to come to resolution on a
    project.
  • Ability
    to mentor, motivate, teach a scientific/technical staff.
  • Offer
    scientific insight to projects.
  • Excellent
    interpersonal skills with the ability to interact effectively with people,
    internally and externally at all levels of the organization.
  • Must
    have exceptional oral and written presentation skills.

Sr

Principal Biostatistican Desired Experience, Skills and Abilities:

  • Record
    of publications (principal author) in methodological research.
  • Extensive
    knowledge of scientific area of responsibility; ability to ask critical
    scientific questions and to critique devised hypotheses, experimental
    designs and results interpretation
  • Demonstrated
    ability to successfully plan and conduct a statistical analysis on
    research.
  • Demonstrated
    ability in supervising scientific/technical work.

Eligibility

Requirements:

  • Must
    be legally authorized to work in the United States without restriction.
  • Must
    be willing to take a drug test and post-offer physical (if required)
  • Must
    be 18 years of age or older

Our

Culture:

Boehringer

Ingelheim is one of the world’s top 20 pharmaceutical companies and operates

globally with approximately 50,000 employees. Since our founding in 1885,

the company has remained family-owned and today we are committed to creating

value through innovation in three business areas including human

pharmaceuticals, animal health and biopharmaceutical contract

manufacturing. Since we are privately held, we have the ability to take

an innovative, long-term view. Our focus is on scientific

discoveries and the introduction of truly novel medicines that improve lives

and provide valuable services and support to patients and their families.

Employees are challenged to take initiative and achieve outstanding results.

Ultimately, our culture and drive allows us to maintain one of the highest

levels of excellence in our industry. We are also deeply committed to our

communities and our employees create and engage in programs that strengthen the

neighborhoods where we live and work. Boehringer Ingelheim, including

Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA,

Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and

Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative

action employer committed to a culturally diverse workforce. All

qualified applicants will receive consideration for employment without regard

to race; color; creed; religion; national origin; age; ancestry; nationality;

marital, domestic partnership or civil union status; sex, gender identity or

expression; affectional or sexual orientation; disability; veteran or military

status, including protected veteran status; domestic violence victim status;

atypical cellular or blood trait; genetic information (including the refusal to

submit to genetic testing) or any other characteristic protected by law.

Boehringer

Ingelheim is firmly committed to ensuring a safe, healthy, productive and

efficient work environment for our employees, partners and customers. As part

of that commitment, Boehringer Ingelheim conducts pre-employment verifications

and drug screenings.