Associate Director Statistical Programming - Biotech

Highly Competitive
  1. Permanent
  2. Programming
  3. Germany
Frankfurt, Germany
Posting date: 25 Oct 2023

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for an Associate Director Statistical Programming - Biotech to join a biotech organisation. This role is on a permanent basis and is located in Frankfurt.


  • Assist with the development and execution of an international programming ecosystem to facilitate successful project deliverables.
  • Write and evaluate programming specifications and validation.
  • You will develop divisional programming standards to meet business requirements and regulatory needs, facilitating effective and seamless production of deliverables.
  • The ideal candidate will set up tools for effective verification of derived datasets, such as SDTM and ADaM, and TLFs.
  • Form novel solutions to standardise, automate and optimise effectiveness and quality to meet business requirements and meet regulatory needs.
  • Contribute to the development and execution of the company's centralised data warehouse.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Comprehension of FDA, EMA, ICH, and international guidelines and regulations, as well as know-how of industry standards suitable to clinical study data and reporting on clinical trials which involves CDISC standards.
  • Educated to a degree level in a statistics, mathematics, computer science or similar field.
  • Demonstrable experience in a pharmaceutical, CRO or any other clinical research environment.
  • Expertise on statistical programming in SAS which involves Base, macro, STAT, GRAPH, SQL, etc.
  • Consciousness of the drug development procedure from early- to late-stage development and proposal.
  • Knowledge of the necessities and technology needed to assist with electronic proposals.
  • Familiarity with guiding proposals and managing individuals.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on

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.