Statistical OR Senior Statistical OR Principal Statistical Programmer
US-BI Pharma/BI USA
 Ridgefield, CT

The qualified candidate will be
hired at the appropriate level commensurate with education/experience

Description:

The Statistical Programmer supports
the clinical research development process by providing statistical programming
for new substances, indications or marketing claims. The Senior Statistical
Programmer supports the clinical research development process by providing
statistical programming for new substances, indications or marketing claims and
is able to function as a Project Statistical Programmer (PPROG), Project
Statistical Programmer for Translational Medicine and Clinical Pharmacology
(PProg-TMCP) or as the Trial Statistical Programmer (TPROG) or Trial
Statistical Programmer for TMCP (TProg-TMCP) focusing on complex trials that
represent new challenges and for which project and therapeutic knowledge is not
given, such as mega trials in new indications. The Principal Statistical
Programmer functionally leads a team of project programmers to fulfil the
magnitude of all necessary tasks, represents the department on
International Working groups, is recognized outside of the company by
manuscript publication and presentations at conferences, and participates in
external associations such as the CDISC standards committees.

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:

  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Utilize BI SOPs and guidelines, trial and project documentation to support the programming requirements of the Medical Quality Review Plan (MQRP), the Trial Statistical Analyses Plan (TSAP) and other supporting reports for trials of Phase I - IV.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Gain specific knowledge about the clinical data collected for the trial. Attend trial meetings as necessary (e.g. Trial Preparation Meeting, Medical Quality Review Meeting, and Blinded Report Planning Meetings). Communicate with other trial team members as needed. Keep management abreast of critical process issues, resource shortages and changes in timelines.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>As a PPROG or PPROG-TMCP, provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of TMCP analyses or safety and efficacy analyses datasets, data files, application programs, and electronic documentation and user manuals. Perform validation activities to ensure the quality of the submission. Keep abreast of international data standards (e.g. CDISC) and supply programming support to the project team to accomplish this requirement from the regulatory authorities.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Review and provide feedback to the trial statistician regarding the scientific portion of the statistical analyses plan and the shell mock-ups for completeness, correctness and adherence to cited department guidelines and SOPs. Author or co-author the Analysis Data Set (ADS) specification with the statistician. Challenge the Technical TSAP to ensure the most standardized and efficient processes can be used for its implementation. Ensure programming issues are resolved and specifications are kept updated in the SAP. Communicate and collaborate with the CRO programmer when any part of the programming is outsourced.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Transform specifications in the Project and Trial Statistical Analyses Plans (P/TSAP) into fully documented and tested programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report. This includes: standard displays that require complex data building programming prior to the call of a standard macro; moderate to complex safety displays that cannot be produced by the use of a standard macro; efficacy displays that require applied statistics knowledge in order to produce well documented tested efficacy programs; and the creation of Analyses Data Sets (ADS) that may require the application of statistical methods; implementation of tables as specified in the MQR plan. Reviews the TLFs across the displays for consistency prior to review by the statistician.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of safety and efficacy data files, application programs, and electronic documentation and user manuals. Performing validation activities to ensure the quality of the submission. Keep abreast of CDISC/ADAM international data structures and supply any programming support to the project team to accomplish this requirement from the FDA.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Ensures data base standards are adhered to and referential integrity is followed.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Help maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid the department's overall efficiency.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>The PPROG develops a project programming strategy with the PSTAT and PDM, involving the trial teams as well. Define critical steps and decisions to be made to enable timely reporting in phase III on trial and project level. Implement project programs as much as possible and enable usage across trials.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Receives broad operating instructions in performing a majority of duties from manager and keeps manager abreast of programming status and issues.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Represents the Statistical Programming function on multi-disciplinary, international working groups, with the ability to lead international working groups.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Helps create or provide training materials in supported area.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Communicate and collaborate with the CRO programmer when part of the trial programming or double programming is outsourced, providing any necessary oversight.
  • line-height:normal;mso-list:l3 level1 lfo1;tab-stops:list .5in“>Proactively propose effective and efficient implementation methods of TMCP related statistical aspects. Translation of statistical analyses of Clinical Pharmacology (CP) and Biomarker (BM) data on trial and project level into programming code using R and SAS. Support the statistical implementation TMCP parts of submission package (e.g. integrated & meta-analysis of PGx, BM, PK/PD) & exploratory data analysis of TMCP trials. Support the development of TMCP specific programming tool box, e.g. clustering, re-sampling, simulations.

Statistical Programmer Requirements:

  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>Bachelor of Science required with a preferred degree (but not limited to) in Bio-/Applied-/ Statistics, Math, and Computer Science (that focus on software and programming language, i.e. C/C , JAVA, PERL, JSP and Python) and a minimum 5 years of statistical programming experience within the pharmaceutical industry, CROs or academic sites is required.
  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>With a Master of Science in the preferred degrees (but not limited to) Bio-/Applied -/ Statistics, Math and Computer Science (that focus on software and programming language, i.e. C/C , JAVA, PERL, JSP and Python), a minimum of 3 years of statistical programming experience is required within the pharmaceutical industry, CROs or academic sites is required.
  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>Proficient in the use of SAS programming language.
  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>Good working knowledge of statistical concepts in support of analyses and reporting of clinical trials.
  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>Knowledge in database structures and set-up.
  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>Knowledge of basic medical terminology.
  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>Ability to work successfully in teams.
  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>Good organizational skills, problem-solving abilities, time management skills and initiative.
  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>Flexibility and ability to work on several assignments simultaneously.
  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>Must be able to work independently as well as part of a team.
  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>Good written and oral communications skills in the English language
  • line-height:normal;mso-list:l4 level1 lfo2;tab-stops:list .5in“>Must be precise, detail oriented, and able to understand data displays and their relation to each other.

Senior Statistical Programmer
Requirements:

  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Bachelor of Science required with a preferred degree (but not limited to) in Bio-/Applied-/ Statistics, Math, and Computer Science (that focus on software and programming language, i.e. C/C , JAVA, PERL, JSP and Python) and a minimum 7 years of progressive statistical programming experience within the pharmaceutical industry, CROs or academic sites is required.
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>With a Master of Science in the preferred degrees (but not limited to) Bio-/Applied -/ Statistics, Math and Computer Science (that focus on software and programming language, i.e. C/C , JAVA, PERL, JSP and Python), a minimum of 5 years of progressive statistical programming experience within the pharmaceutical industry, CROs or academic sites is required
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>International business experience
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Proven experience within the pharmaceutical industry, CROs or academic sites, covering MQR programming and all CTR aspects - ADS / TFLs.
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming.
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Having knowledge of all phases of drug development, including R&D, early and late clinical development and submission
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Having background of applied statistics
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Knowledge of new advanced statistical methods using R and SAS
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Knowledge in database structures and set-up
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Knowledge of basic medical terminology
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Ability to work successfully in teams.
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Good organizational skills, problem-solving abilities, time management skills and initiative.
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Flexibility and ability to work on several assignments simultaneously.
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Must be able to work independently as well as part of a team.
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Good written and oral communications skills in the English language
  • line-height:normal;mso-list:l0 level1 lfo3;tab-stops:list .5in“>Must be precise, detail oriented, and able to understand data displays and their relation to each other.

Principal Statistical Programmer
Requirements:

  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Bachelor of Science required with a preferred degree (but not limited to) in Bio-/Applied-/ Statistics, Math, and Computer Science (that focus on software and programming language, i.e. C/C , JAVA, PERL, JSP and Python) and a minimum 10 years of statistical programming experience within the pharmaceutical industry, CROs or academic sites is required.
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>With a Master of Science in the preferred degrees (but not limited to) Bio-/Applied -/ Statistics, Math and Computer Science (that focus on software and programming language, i.e. C/C , JAVA, PERL, JSP and Python), a minimum of 8 years of statistical programming experience is required within the pharmaceutical industry, CROs or academic sites is required.
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>One (1) to three (3) years project management experience
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>International business experience
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Proven experience within the pharmaceutical industry, CROs or academic sites
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming.
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials.
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Having knowledge of all phases of drug development, including R&D, early and late clinical development and submission
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Having solid background of applied statistics
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Solid knowledge of new advanced statistical methods using R and SAS
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Knowledge in database structures and set-up
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Knowledge of basic medical terminology
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>The person carrying out this function has successfully provided programming expertise at the Project level for at least two large and complex international development projects that have been submitted to regulatory agencies worldwide and is an expert statistical programming resource for the department.
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Ability to work successfully in teams.
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Good organizational skills, problem-solving abilities, time management skills and initiative.
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Flexibility and ability to work on several assignments simultaneously. Must be able to work independently as well as part of a team.
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Good written and oral communications skills in the English language
  • line-height:normal;mso-list:l1 level1 lfo4;tab-stops:list .5in“>Must be precise, detail oriented, and able to understand data displays and their relation to each other.

Eligibility Requirements:

  • line-height:normal;mso-list:l2 level1 lfo5;tab-stops:list .5in“>Must be legally authorized to work in the United States without restriction.
  • line-height:normal;mso-list:l2 level1 lfo5;tab-stops:list .5in“>Must be willing to take a drug test and post-offer physical (if required)
  • line-height:normal;mso-list:l2 level1 lfo5;tab-stops:list .5in“>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.

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