Biotech/Pharmaceutical

Principal Biostatistician – Remote

Permanent

Penfield Search Partners

Contact: Mark Maurer – mmaurer@penfieldsearch.com

Description: Supports the clinical drug research and development process by providing strategic planning and execution, including data transformation and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to clinical projects like actual trial data, registries and real-world data bases. In particular this includes the provision of analytics tools, outputs and inference as necessary for the specific use case.  May act as a BDS product owner up to Therapeutic Area/asset level. Represent BDS at a substance/asset level regarding data science related aspects.

As an employee, 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 company’s high regard for our employees.

Duties & Responsibilities:

  • Subject Matter Expert (SME) / Process Lead for designing as well as transforming, analyzing and reporting complex phase I-IV clinical trials that represent new challenges and for which project and therapeutic knowledge is not given, such as mega trials or new indications and for complex international R&D projects.
  • Subject Matter Expert (SME) / Process Lead for designing as well as transforming, analyzing and reporting of other data that represent new challenges from research and development like registries and real-world data bases.
  • Identify trends in data science within and outside company. Initiate and Turn derived insights into new data science approaches relevant for clinical development, registration, and marketing of drugs.
  • Present compelling validated stories regarding complex data science aspects to BDS colleagues, other professionals within and outside of company and laymen.
  • Ensure data transformation and analysis specifications to ensure completeness, correctness and adherence to department guidelines and SOPs as well as to applicable GxP requirements.
  • Lead/Guide other colleagues, internal and external customer and external providers on data science related tasks.
  • Lead cross-functional company internal working-groups and drive/plan relevant data science aspects. Participate in external working groups.
  • If applicable, supports the clinical drug development process as a BDS Product Owner up to the level of Therapeutic Area/assets.
  • Facilitates and ensures cross-functional and team-based working within BDS and with the rest of the company. Fulfils tasks of other functions as needed and possible. Contributes to cross-functional- and team-based thinking.
  • Fosters innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models.

Requirements:

  • Bachelor of Science (BSc) from an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.), with a minimum of ten (10) years of data science experience; Or
  • Master of Science (MSc) from an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.), with ten (10) years of experience within the pharmaceutical industry, CROs, regulatory authorities or academic institutions; Or
  • Doctoral Degree (PhD) from an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.), with six (6) years of experience within the pharmaceutical industry, CROs, regulatory authorities or academic institutions.
  • Working experience might be partially compensated by broad and deep topic-specific knowledge.
  • Comprehensive knowledge and advanced experience in software languages relevant for business needs.
  • Comprehensive knowledge and advanced experience in understanding of clinical trial development process required.
  • Broad knowledge and advanced project lead experience required.
  • Experience in agile project methods.
  • Understanding and applying key of principles of data science.
  • Demonstrated comprehensive knowledge in planning, transforming, analyzing, interpreting, and reporting data in complex situations that represent new challenges and for which project and therapeutic knowledge is not given.
  • Excellent knowledge of statistical methodology, design of clinical trials or clinical experiments, basic medical terminology and on processing clinical trial information.
  • Advanced understanding of cutting-edge statistical concepts related to Data Science.
  • Comprehensive working knowledge of broad variety of aspects of relevant software languages.
  • Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.
  • Ability to lead and facilitate meetings.
  • Ability to develop and deliver training related to data science topics.
  • Evidence of strong teamwork, also in global and remote context.
  • Good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g. CROs, experts, management).
  • Ability to pro-actively identify issues and solutions and to interact with internal and external bodies on routine data science issues.
  • Language skills: English: fluent (Read/Write/Speak).

Know, understand, and implement:

  • International regulations and guidelines for good clinical and statistical practice from all ICH regions,
  • The various international guidelines on clinical development, including statistical methodology, for TA-related disease areas, and
  • Company processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g. Clinical Development Plan).

Tagged as: Principal Biostatistician Remote