Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany; New Jersey, US | full time | Job ID: 11339
About the Role:As Associate Director Statistical Programming you will be responsible for representing Statistics in all assigned cross-functional clinical study teams and other projects and holding accountability for all statistical aspects, as well as for providing statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables.
Your Contribution:- Work as part of a collaborative, cross-functional team with members from other discipline
- Perform and/or verify sample size calculations
- Lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results
- Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
- Oversee outsourced statistical CRO activities and deliverables ensuring highest quality and in a timely manner
- Support and participate in the development of departmental strategies
- Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
- Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met
A Good Match:- PhD or Masters in (Bio)Statistics, Mathematics or equivalent
- Minimum 5 years (8 years for masters) in the pharmaceutical industry and/or CRO
- At least 3 years of work/leadership experience, overseeing statistics staff (internal as well as outsourced) and in representing Biostatistics in a matrix organization and in a multidisciplinary team
- Experiences in planning, conducting and analyses of oncology or infectious diseases trials from phase I-IV, including scientific publications
- Experience in answering health authority questions (FDA, EMA) and in leadings statistics on regulatory submissions, including developing ISE/ISS packages
- Good knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus), regulatory guidelines (ICH, FDA, EMA)
- Good knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
- Very good understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus
- Very Good analytical skills and bility to analyze complex issues to develop relevant and realistic plans, programs, recommendations, risk mitigation strategies, and the ability to communicate them to cross functional colleagues
- Strong drive for achieving high quality working results in a timely manner, while always safeguarding ethical standards in work and behaviors
Your remuneration:If the position is filled in the US, the Expected Pay Range is $146,300/year to $234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
Compensation at other locations may vary significantly.
