[Statlist] Full-time, temporary (1 y) position in Biotechnology company (Neuchâtel area)

[Anne May]

Role: Independent contractor - Statistician / Statistical Support - 100% - Temporary (1 year) – Start as soon as possible
Location: Biotechnology company – Neuchâtel area

Prerequisites: MSc. or PhD in Statistics, Bio-Informatics, Data Science or similar area;

Prior experience in biostatistics supporting clinical research in Industry or CRO

Responsibilities:

1.     Under the supervision of the Director, Biostatistics, lead several post-approval safety studies.

2.     Actively provide statistical support to the WWM Medical Affairs Department.

·      Provide statistical input into the design of protocols including preparation of the biostatistical section. Suggest optimal statistical designs that are acceptable by regulators and reimbursement bodies.

·      Prepare statistical analysis plans including table shells.

·      Analyze and report results of clinical studies and registries. Provide tables, listings and other required documents.

·      Provide statistical support for integrated reports, submissions preparation, and post-submission activities.

·      Support preparation of manuscripts.

·      Provide project requirements to programmers.

·      Serve as statistical lead on studies.

3.     Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.

4.     Perform programming validation to ensure quality of analysis datasets and programming outputs.

5.     Participates in cross-functional collaboration and provide statistical advice on the study/project conduct.

Skills/Knowledge Required:

§  MSc or PhD in statistics and a minimum of 3 years of experience in a biostatistics department; or documented 5-year experience in biostatistics associated with a recognized degree or certificate in statistics.

§  Documented experience and real working programming skills in using SAS and R. Strong ability to perform hands-on work required.

§  Strong analytical skills.

§  Detailed knowledge of statistical regulatory requirements; regulations and currently acceptable statistical methodology.

§  Demonstrated skills in using MS Office products (Word, Excel, PowerPoint). Knowledge of MS Office macros and Visual Basic could be a plus.

§  Good interpersonal, communication, writing and organizational skills. Demonstrated ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers.

§  Fluency in English.

Additional skills / knowledge that will be a plus:

§  Experience in developing PASS studies and reporting in PSURs.

§  Experience with CAR-T products.

Contact:

§  Interested in this position? Please apply to info using consultantsinscience.com <mailto:info using consultantsinscience.com>
§  For additional questions, please contact Joanna Jones, Head of Recruitment, Consultants in Science, Biopole – CH 1066 Epalinges (joanna.jones using consultantsinscience.com <mailto:joanna.jones using consultantsinscience.com>, +41 78 619 76 70)

 
Anne May, PhD

anne.may using consultantsinscience.com
+41 (0)79 468 55 46
Biopôle SC-A - CH 1066 Epalinges