Position Purpose:
Responsible for leading and coordinating activities for the development, validation, and execution of all statistical deliverables within assigned scope (study or project) for compounds within clinical development and/or medical affairs.
Create and maintain project plans including timelines, resource planning, and risk assessments for planned and exploratory requests.
Major Tasks and Responsibilities:
Create or contribute to SAP, TLF, SDTM/ADaM and submission relevant documentation for clinical trials, where applicable
Lead statistical programming and validation activities for clinical study/integrated programming requests in close collaboration with statistical teams
Lead, prepare, and coordinate activities of assigned statistical programming team deliverables for submissions and health authority question responses for all regions, Medical Affairs, HEOR, RWE, and other functions within the organization.
Provide mentoring/coaching to other analysts in the development of statistical programs and interpretation of results. Manage, lead, and provide guidance to external programmers and analysts.
Collaborate with Statisticians on the implementation of new methodologies, statistical method issues in conjunction with subject matter experts
Represent Statistical Analytics in Global Submission teams, ensuring compliance with global health authority requirements and industry standards
Provide expertise on the evaluation of process and system requirements including recommendations for improvements
Represent Bayer at external conferences; actively participate in industry statistical programming workshops and working groups as required.
Who you are?
MS in Statistics, or Mathematics, Computer Science, Natural or Environmental Sciences, Informatics, or related field or equivalent (of theoretical/technical depth)
+ 5 years of experience in statistical programming or statistics in the pharmaceutical or biotechnology industry using SAS.
Statistical analysis experience in Oncology required.
Have a thorough knowledge of Databases, CDISC standards (SDTM/ADaM and Implementation Guides) and be well connected with the industry working groups.
Experience in creating and maintaining SDTM/ADaM datasets and databases, including metadata and corresponding documentation especially in submission context and specific requirements (define.xml, creation of xpt files).
Experience in contributing and creating SAP, TLF and dataset specifications.
Experience with submissions to health authorities (EMA. FDA, PMDA, NMPA) and different requirements as well as other contributions (TLF for CSR, BIMO, OSI, RMP, CCDS …).
Hands-on experience in integrated analysis (e.g. data pool creation, contribution to ISS/ ISE) is an asset.
Technical Skills:
In-depth knowledge of statistical methodology used to analyze, interpret, and deep understanding of data, i.e., efficacy analysis, EAIR, the use of confidence intervals, hazard ratios, and p-values etc.
Excellent computer skills and data analysis knowledge.
Possess ability to understand intricacies of various oncology study designs and comprehend analysis plans which may describe methodology to be programmed.
Preferrable experience with other software and languages like R, R Shiny, PythonSpotfire, Tableau.
Hands-on experience with industry standard software (e.g. Pinnacle 21(E)).
Your Application:
At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Reward is important to us, employees benefit from excellent employment conditions, such as:
competitive salary and performance bonus
25 days annual leave plus bank holidays
Private Healthcare, generous pension scheme and Life Insurance
Employee discount scheme
State of the art offices (award winner for British Council for Offices, Best Fit Out Category 2018)
International career possibilities
Flexible working
