Contract Statistician (Munich, Germany)

If interested please contact Kien-Sen Lee at: Kien-Sen.Lee [at] hayspharma.com or on +44 (0) 20 7922 7126.

Our clients based in South Germany and are actively searching for an experienced Contract Statistician, they are considering allowing some home working flexibility and are looking to pay competitive rates. This role is initially for 6 months but with opportunities to extend.

You will be working in phases I - III within the Respiratory and GI therapeutic areas.

DUTIES

• Write detailed statistical analysis plans for clinical trials as well as for integrated summaries of efficacy and safety.
• Analyse clinical trial data producing accurate results representing the outcome of the trial.
• Validate statistical output.
• Accurately interpret and clearly communicate statistical results and concepts to non-statisticians.
• Co-author final integrated reports of clinical trial data writing thorough and clear statistical methods sections and producing the statistical appendix for the reports.
• Provide statistical output as required for manuscripts and ensure that the results are accurately interpreted in the publications.
• Provide input into statistical SOPs and general standardization efforts within the department (e.g. statistical methodology standards, standard data presentations).
• Participate in interactions with regulatory agencies as required.
• Collaborate effectively with members of clinical trial implementation teams and with Biometrics colleagues.

• Language and Education
• Fluency in English.
• Ph.D. or MSc in Statistics or Biostatistics or equivalent, with extensive and broad pharmaceutical/ biotechnology -experience.
• Professional Skills and Experience
• Working SAS knowledge and proficient in SAS statistical procedures.
• Knowledge of ICH statistical regulatory requirements.
• Personal Qualifications
• Interpersonal skills, initiative, creativity.
• Excellent communication skills.

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