Principal Statistician / Senior Principal
***Candidate will be
hired commensurate with the level and experience***
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.
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.
- Performduties of a Trial Statistician to support complex clinical trials withinnational or international development projects or for marketed products asrequired. Collaborate with members of Clinical Research andMarketing, Trial Clinical Monitor and trial teams incl. pharmacokineticistin planning clinical trials and protocols conforming to company andregulatory agency guidelines and/or marketing and publication strategies.
- Actas Project Statistician for early projects, backup projects, orprojects with established BI experience.
- SupportProject Statisticians of high profile international projects in theirresponsibilities, especially in their statistical responsibilities in theplanning and preparation of regulatory submissions and contribute toefforts on cross-trial planning and harmonization.
- Analyzedata from phase I to IV trials incl. responsibility for programvalidation. Perform exploratory analyses in collaboration with theProject Statistician.
- Prepareaccurate, high quality reports of complex clinical trials for registrationof drugs and biologics, publications and management.
- Preparespecifications for data analyses by outside vendors as required.Assure compliance with the specifications by reviewing the vendors'products.
- Participateon assigned international teams to promote harmonization efforts forclinical drug development.
- Supportmanagement in resource planning and tracking for assigned trials andprojects.
- Actas a team leader for a complex project or mega-trial who
- Ensuresteam members adhere to the SOPs, guidelines and local workinginstructions.
- Attendsall the meetings related to the trial/project needing a statistical input(or send delegates) and send minutes to the team members
- Assistthe Head of programming and Head of statistics with the working ofvendors, contractors in establishing procedures for programming andvalidating statistical analysis (writes the scope of work, preparedocuments to be sent to the contract research organization (CRO). From astatistical perspective, is the primary contact for CROs (programming validation)
- Actsas a Trial or Project Statistician (TSTAT or PSTAT) for thetrial/project. In particular, develops report and programmingspecifications in a Trial Statistical Analysis Plan (TSAP) and update thisdocument as often as needed.
- Collaboratewith the programming group and the data management group to submit verydetailed timelines for the trial/project to clinicians. Meeting agreedupon timelines are essential to the success of the clinical trial/projectteam objectives
- Froma statistical perspective, is the primary contact for medical writing (orchoose a designee)
- Ensuresthat protocol objectives are met and project standards are maintained(also responsible to update the project statistical analysis plan whennecessary
- Ensuresachievement of major statistical deliverables and milestones incoordination with other functions including Clinical Research, Safety,Statistical Programming, Data Management and Medical Writing
- Providesand organizes statistical support for regulatory meetings, questions andsubmissions.
- Informsmanagement that hours allocated to TSTAT by the capacity algorithm shouldbe updated (follow up the amount of hours entered in the time recordingsystem and related to the trial/project)
- Ensuresefficient work within the team by setting priorities and avoiding overlapsbetween team members
- Worksdirectly and proactively with the Trial, Project or Substance team.
- Assumesresponsibility for the coordination of all relevant statistical activitiesfor a Trial, Project or Substance.
- Receivesbroad operating instructions in performing a majority of duties frommanager and keeps manager abreast of programming status. Alerts managementin case of resources issues, timelines problems or conflicts within theteam
- Incollaboration with the statistical expert group member, maintain expertisein therapeutic area, by keeping abreast of new publications with thepurpose of increasing the overall efficiency or effectiveness in thedepartment.
- Masters’degree from an accredited institution required and 6 years'experience within the pharmaceutical industry, CROs, regulatoryauthorities, or academic institutions, or Doctoral degree (PhD, MD)from an accredited institution with 3 years' experience within thepharmaceutical industry, CROs, regulatory authorities, or academicinstitutions.
- Abilityto interact with authorities on statistical issues at the trial level.
- Thoroughknowledge of statistical methodology, processing clinical trial informationand the drug development process.
- Abilityto communicate statistical information to non-statisticians.
- Abilityto write publications (as joint author) in clinical trials.
- Excellentoral and written communication skills.
- Abilityto manage project from a statistical perspective.
- Demonstratedability to design, conduct and analyze a complex trial
- Evidenceof strong teamwork in order to successfully work with a trial team andproject level team members
Principal Biostatistican Requirements:
- Ph.D. in statistics, biostatistics, or biometry; atleast 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.
- Abilityto work on local/global project teams in order to come to resolution on aproject.
- Abilityto mentor, motivate, teach a scientific/technical staff.
- Offerscientific insight to projects.
- Excellentinterpersonal skills with the ability to interact effectively with people,internally and externally at all levels of the organization.
- Musthave exceptional oral and written presentation skills.
Principal Biostatistican Desired Experience, Skills and Abilities:
- Recordof publications (principal author) in methodological research.
- Extensiveknowledge of scientific area of responsibility; ability to ask criticalscientific questions and to critique devised hypotheses, experimentaldesigns and results interpretation
- Demonstratedability to successfully plan and conduct a statistical analysis onresearch.
- Demonstratedability in supervising scientific/technical work.
- Mustbe legally authorized to work in the United States without restriction.
- Mustbe willing to take a drug test and post-offer physical (if required)
- Mustbe 18 years of age or older
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.
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.