Principal / Senior Principal Statistician ( Clinical Trial Development)
Principal / Senior Principal Statistician ( Clinical Trial Development)
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1 Vacancy
Job Description
Principal / Senior Principal TA Methodology Statistician (HTA and Market Access)
Remote
Full Time
Ideal Candidate
Experience with clinical trial development not just at the trial level but the overall asset development process.
Solid knowledge/learning abilities on statistical methodology
Focus on talent with a pharma background as being the ideal
HTA health technology assessment knowledge this is related to global reimbursement process
Market Access knowledge
Duties & Responsibilities
In your new role you will closely collaborate with other statisticians and provide statisticalmethodological expertise on multiple of the following topics:
integration of external data into clinical development and HTA reports e.g. via usage of Bayesian borrowing and external control
complex evidence synthesis including Bayesian network metaanalysis
patientfocused drug development including clinical endpoint development and psychometric validation of instruments
clinical trial design that enables RCT generalizability to real world populations and settings for example pragmatic trial and flexible augmented clinical trial for improved evidence generation (FACTIVE)
target trial emulation causal inference and real world evidence methodology
You will evaluate advanced statistical methods to foster holistic evidence generation by prototyping and developing readytouse toolkits. you will drive their implementation.
You will contribute to the largescale implementation for such innovation toolkits.
You will provide pragmatic solutions to our clinical development teams to foster holistic evidence generation that accompanies needs for different stakeholders including internal decision making regulatory market access and medical affairs.
You will present and quantitively illustrate the application of complex statistical concepts to stakeholders like management external partners and/or regulatory agencies.
Furthermore you will provide statisticalmethodological trainings to statisticians and nonstatisticians.
Additionally you will mentor and guide other colleagues. You will define and supervise the technical and scientific work of interns and students and contribute to their professional journey.
Principal Requirements:
Master of Science (MSc) or Doctoral Degree (PhD) from an accredited institution in Statistics or Mathematics or related field (Psychology Data Science Finance etc.).
At least five (5) years of experience as a statistician or data scientist in an area relevant for the specific role
Senior Principal Requirements:
Master of Science (MSc) or Doctoral Degree (PhD) from an accredited institution in Statistics or Mathematics or related field (Psychology Data Science Finance etc.).
At least seven (7) years of experience as a statistician or data scientist in an area relevant for the specific role.
Additional Requirements:
Working experience might be partially compensated by broad and deep topicspecific knowledge e.g. with respect to statistical methodology.
Statistical experience gained in an international context and ideally in different companies/ academic institutions.
Ideally additional qualification and experience in a leadership role.
Indepth knowledge of competitor and agency strategies and/or indepth knowledge regarding statistical approaches developed and implemented by other companies or academia in a global context.
Indepth knowledge of parts of BDS and related parts of other organizations at BI regarding their contribution to BIs strategy.
Indepth knowledge of statistical methodology and clinical development.
Indepth understanding of statistical concepts related to clinical development.
Ability to supervise scientific/technical work.
Proficient in the use of software languages to implement statistical concepts.
Mindful of local global internal and external cultures to ensure that messages are received positively and effectively.
Ability to lead and facilitate meetings required.
Evidence of strong teamwork ideally also in global and remote context.
Very good interpersonal skills with the ability to interact effectively with people internally and externally (e.g. CROs experts management).
Ability to proactively identify issues and solutions and to interact with internal and external bodies on statistical topics.
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 data standardization and
BI processes and SOPs that govern clinical development in particular with respect to strategic areas e.g. Clinical Development Plan)
Skills and Certifications
Statistical Methodology
Clinical Development
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- Business Development
- Classroom Experience
- Dayforce
- Go
- Cloud Computing
- AWS
- Teaching
- Administrative Experience
- Leadership Experience
- negotiation
- SAS
- Data Analysis Skills
