Senior Statistical Programmer 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 Principal Statistical Programmer supports the clinical research development process by providing statistical programming for new substances, indications or marketing claims. Is able to function as a leading Project Statistical Programmer (PPROG), leading Project Statistical Programmer for Translational Medicine and Clinical Pharmacology (PProg-TMCP) for a development project approaching submission. The principal statistical programmer functionally leads a team of project programmers to fulfil the magnitude of all necessary tasks.

The Principal Statistical Programmer works directly with the project statistician and proactively with the Clinical Trial and Project teams, providing programming support and programming concepts. Additionally, this position implements and supports standards and a harmonized approach to programming.

Represents the department on International Working groups, is recognized outside of the company by manuscript publication and presentations at conferences. Participates in external associations such as the CDISC standards committees.

Responsible for developing, reviewing and approval of validation plans, protocols, and reports. Reviews and interprets data for accuracy and responsible for approval of final report packages.

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:

  • As a mentor to other programmers, ensures staff members adhere to the SOPs, guidelines and local working instructions. Assist in the updating of these documents as requested by the manager. Assists in the development of department procedures and processes to gain efficiencies. Communicates with the Contract or Academic programmer when part of the trial programming or double programming is outsourced.
  • As a principal project programmer, lead a team of programmers located in different OPUs and distribute work packages accordingly. Monitor implementation of the work packages and train assigned programmers in the programming concept. Implement documentation and tracking tools.
  • 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.
  • Review and provide feedback to the project 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 and PSAP 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.
  • Transform specifications in the Project Statistical Analyses Plans (PSAP) 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; and implement tables as specified in the MQR plan. Reviews the TLFs across the displays for consistency prior to review by the statistician.
  • 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.
  • 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.
  • Delegate parts of programming development to other team members, providing necessary oversight. Communicate and collaborate with the CRO programmer when part of the trial programming or double programming is outsourced, providing any necessary oversight.
  • Receives broad operating instructions in performing a majority of duties from manager and keeps manager abreast of programming status and issues.
  • Represents the Statistical Programming function on multi-disciplinary, international working groups, with the ability to lead international working groups, FDA or industry developed committees.
  • Helps create or provide training materials in supported area.
  • 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. Responsible for statistical implementation TMCP parts of submission package (e.g. integrated & meta-analysis of PGx, BM, PK/PD) & exploratory data analysis of TMCP trials. Development of TMCP specific programming tool box, e.g. clustering, re-sampling, simulations.

Senior Statistical Programmer Requirements:

  • 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.
  • 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
  • International business experience
  • Proven experience within the pharmaceutical industry, CROs or academic sites, covering MQR programming and all CTR aspects - ADS / TFLs.
  • Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming.
  • Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials
  • Having knowledge of all phases of drug development, including R&D, early and late clinical development and submission
  • Having background of applied statistics
  • Knowledge of new advanced statistical methods using R and SAS
  • Knowledge in database structures and set-up
  • Knowledge of basic medical terminology
  • Ability to work successfully in teams.
  • Good organizational skills, problem-solving abilities, time management skills and initiative.
  • Flexibility and ability to work on several assignments simultaneously.
  • Must be able to work independently as well as part of a team.
  • Good written and oral communications skills in the English language
  • Must be precise, detail oriented, and able to understand data displays and their relation to each other.

Principal Statistical Programmer Requirements:

  • 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.
  • 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.
  • One (1) to three (3) years project management experience
  • International business experience
  • Proven experience within the pharmaceutical industry, CROs or academic sites
  • Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming.
  • Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials.
  • Having knowledge of all phases of drug development, including R&D, early and late clinical development and submission
  • Having solid background of applied statistics
  • Solid knowledge of new advanced statistical methods using R and SAS
  • Knowledge in database structures and set-up
  • Knowledge of basic medical terminology
  • 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.
  • Ability to work successfully in teams.
  • Good organizational skills, problem-solving abilities, time management skills and initiative.
  • Flexibility and ability to work on several assignments simultaneously. Must be able to work independently as well as part of a team.
  • Good written and oral communications skills in the English language
  • Must be precise, detail oriented, and able to understand data displays and their relation to each other.

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.

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