Associate Director Statistical Programming - Frankfurt am Main, Deutschland - ProClinical

ProClinical

Geprüftes Unternehmen

Frankfurt am Main, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Salary:

Highly Competitive

Job type:

PermanentDiscipline:

Programming
Location:
Germany- Frankfurt, Deutschland

Posting date: 08 Feb 2024

Reference:
58841

Proclinical are partnering with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis with the ability to work remotely from anywhere in Germany. The opening position that is currently available is for an Associate Director Statistical Programming.

Responsibilities:

Assist with the development and execution of an international programming ecosystem to facilitate successful project deliverables.
Contribute to the development and execution of the company's centralised data warehouse.
Form novel solutions to standardise, automate and optimise effectiveness and quality to meet business requirements as well as regulatory needs.
You will set up tools for effective verification of derived datasets such as SDTM and ADaM, and TLFs.
Produce ad hoc datasets and TLFs on an ongoing basis.
Write and evaluate programming specifications and validation.
Other duties may be assigned.

Key Skills and Requirements:

Educated to a degree or advanced degree level in a statistics, mathematics, computer science or similar field.
Demonstrable experience within a pharmaceutical, CRO, or any other clinical research environment.
Expertise on statistical programming within SAS which involves Base, macro, STAT, GRAPH. SQL, etc.
Comprehension of FDA, EMA, ICH and international guidelines and regulations, as well as knowhow of industry standards suitable for clinical study data and reporting on clinical trials, which involves CDISC standards.
Consciousness of the drug development process from early

- to late-stage development and proposal.

Knowledge of the needs and technology necessary for assisting with electronic proposals.
Acquaintance with guiding proposals and managing others.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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