Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. 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.
Principal TA SDTM Specialist
Major Tasks and Responsibilities:
- Supports the tasks of the Expert position and tasks over responsibility on a compound with support of the respective TA Expert Ensure effective collaboration and open communication lines and interfaces across DS&A with a focus on compound alignment for CDISC SDTM and ADaM data.
- Responsible for consistent application of processes throughout life of compound by providing oversight of the entire process.
- Gives guidance and mentors SDTM operations on establishing standard on study level.
- Lead SDTM operations members working within a compound.
- Coordinate activities of SDTM operations to ensure timely delivery and receipt of study and high quality submission deliverables related to SDTM such as regulatory reviewer’s guides, SDTM annotated CRFs for assigned compound(s).
- Complement to other therapeutic area / compound level roles within SPA and in DS&A § Interacts with SPA Industry and Regulatory Interaction group (SIRI).
- Supports the TA expert in his role as overall submission lead coordinating compilation of high quality submission packages (data, documentation, programs).
- Supports SIRI for data related topics at regulatory agency meetings for assigned compound(s).
- Perform content related oversight of outsourced trials on deliverables in scope of this function
Who you are?
- MS or BS in Statistics, Mathematics, Computer Science, Natural Sciences, Informatics, or related field or equivalent (of theoretical/technical depth)
- Experience in statistical programming or statistics in the pharmaceutical or biotechnology industry.
- Must have good communication and interpersonal skills
- Essential experience in CDISC & SDTM creation
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
Are you up for the challenge? If so, please apply below.
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 497943
Functional Area: Clinical Development & Operations