Statistician – Biometrics CRO Oversight
Statistician Biometrics
Life Science department within Technogarden is now looking for a skilled Statistician for an assignment on-site part time in Scania! We are looking for a statistician with fairly long experience who also can program in SAS and who can work for us about 50% for at least one year. The assignment is on site, at our clients HQ in Lund.
It is of importance that you have excellent cooperation skills and like working in a biometrics team and also participate in inhouse trial team as the inhouse trial statistician together with different functions.
If you appreciate:
- High speed at work and the upper management is very involved, and may ask direct questions meeting with stat.
- High flexibility and confidentiality
- Important to keep deadlines
Your responsibilities:
- Oversight of CROs Stat/prog activities
- Give input to relevant section in the Clinical Trial Protocol and approve/sign off
- Lead or write SAP for a trial and for other non-study analysis of data and sign off
- Give input to relevant biometrics documents
- Lead and review shells and dry-run TFLs from CROs
- QC of program, if required
- Review and approve Clinical Trial Reports
- Give input to clinical programs, study designs and sample size calculation
- Perform statistical analyses, tables e t c on clinical data
- Keep up-to-date with statistical methodology relevant to the pharmaceutical industry and share knowledge
- Participate in regulatory meetings with authorities, if required
Candidate profile:
- University degree in statistics
- Experience within Statistics in the pharmaceutical industry and at a clinical CRO
- Experience in sas-programming
- Experience in CDISC
- Excellent communication skills
- Fluent in written and spoken English
Technogarden offers interesting assignments and we are a well established company where you will belong to a tight, inspiring team both within Technogarden and at our client! We need you urgently and look forward to our first discussion to see if this is a match for you! Don´t hesitate to contact us for further questions and information.