Sr. Biostatistician
Soliant Health (Washington, Washington DC)

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Joint the team of one of the world's largest pharmaceutical/biotech companies in the Gaithersburg , MD area.

Sr. Biostatistician

Main task: to support the creation of a proper statistical analysis. A statistical analysis that answers the clinical scientific questions posed in the trial protocol in such a way that a clear clinical trial report can be written.

Detailed list of tasks:

            -Co-operate in the design of a clinical trial protocol, the sample size calculations and the writing of the statistical section in the protocol.

         - Create randomisation lists and code envelopes.

         -      Review the draft case report form (CRF).

         -         Write and review the statistical analysis plan (SAP) for phase I – IV.

         -         Program and review (validate) SAS macros.

                  Program and review (validate) the statistical analysis, possibly in co-operation with a biostatistical analyst (BSA) or another BST.

        -       Write and review statistical reports.

      -         Review the clinical study report (CSR).

      -          Coach colleages.

         Support Business Development (BD) in the generation of budget proposals.

               RESPONSIBILITIES AND PRIMARY TASKS

              Clinical trial protocol

Participate in discussions with the Project Responsible (PR) and the sponsor.

  Co-operate in designing the clinical trial (design and assessments), to ensure that the trial follows sound scientific methodology.

-        Perform and/or review sample size calculations.

-        Write and/or review the statistical methods sections of the protocol.

-        Perform an overall review of the entire protocol.

             Randomisation

-        Create and/or review the randomisation list.

-        Create and/or review the code envelopes.

-        Create new studies in the central randomisation software, and give support to the system users.

           Case report form (CRF)

-        Review the draft CRF.

-        Give (constructive) input in the design of specific assessment pages.

-        Review the annotated CRF.

          Statistical analysis plan (SAP)

-        Create and/or review the SAP, based on the protocol, protocol amendments and (annotated) CRF. Phases  I – IV.

-        Approve the SAP written by another BST or BSA.

            SAS macros

-        Create/write new macros.

-        Review the code of a new macro.

-        Validate a new macro.

-        Solve programming errors in existing macros.

            Statistical analysis

-        Write the analysis programs, possibly in co-operation with another BST or BSA.

-        Create SAS datasets for sponsor use, when applicable.

-        Review (validate) the statistical analysis and the analysis programs.
If required, perform independent programming of the main parameters.  Comply to the appropriate analysis validation model.

-        Solve programming errors.

-        Release a statistical analysis when the validation has passed.

        Statistical reports

-        Liaise with the PR and the sponsor to define the expected contents of the report document (topline results report or statistical study report).

-        Write and/or review the statistical report.

            Clinical study report (CSR)

-        Give input to the Medical Writer (MW) during the writing process; when necessary explain the statistical methodology used in the statistical analysis.

-        Ensure the MW has all documentation necessary for report writing.

-        Review the draft CSR; both a QC on the numbers as well as a check on contents and interpretations.

            Coaching

-        Assist BSTs and BSAs when they encounter methodological or coding problems.

-        Assist other departments (medical writing, data management, data review, clinical research,…) whenever they encounter problems or have questions related to statistics.

            Business Development

-        Review and/or give input to BD in the generation of new budget proposals.

-        If necessary, assist BD in customer liaisons.

                    COMMUNICATION

      INTERNAL COMMUNICATION:

-        Biometrics manager (BIOM): items related to the biometrics department.

-        BSTM: items related to statistics in general, and items related to the biostatistics department.

-        Other BSTs and BSAs: items related to statistics and SAS programming.

-        PR: related to protocols and CRF, or trial conduct.

-        Project manager for biometrics (PM-BIOM) for project-related items.

-        CRF designer: related to CRFs.

-        Data manager and data reviewer: project-related questions on the quality and/or contents of the clinical database.

-        MW: related to the creation of the CSR and the interpretation of the analysis.

-        Pharmacokineticist: related to aspects of PK/PD analyses and interpretations.

-        BD: related to budget proposals and customer contacts.

            EXTERNAL COMMUNICATION:

-        Sponsor: biometrics responsible: statistics-related issues on protocols, SAPs and hence analyses, and CSR.

-        Sponsor: clinical research responsible: statistics-related issues on protocols, designs and sample size estimations.

                 PREREQUISITES

         QUALIFICATIONS/EDUCATION

-        University Master’s degree in science (e.g., mathematics, biology, …)

-        Master of Science in Biostatistics or Statistics, OR performed a similar relevant function for at least one year in another institution (e.g., teaching statistics at university level)

-        Able to program in SAS®

  EXPERIENCE

Should be able to coach (junior) BSTs and BSAs. Should have been involved in at least 20 phase II – IV studies (including pooled analyses) and at least 10 phase I studies (there are considered of lesser importance to a Senior BST). Should have reviewed at least 10 CSRs of phase I – IV studies.

 SPECIFIC REQUIREMENTS AND/OR COMPETENCES

Additional requirement and/or competences:

-          Remain flexible.

-          Preserve confidentiality.

-          Respect budgets and timelines.

-          Be open to other people’s opinion; prepared to listen and willing to learn.

-          Display a positive, constructive, professional attitude towards colleages and sponsors.

-          Able to communicate statistical matters in a clear and understandable way to statisticians as well as non-statisticians.

-          Be (and remain) critical towards own work and other people’s work.

-          Be (and remain) critical towards the standard operating procedures.

-          Document and program in an orderly fashion.

Requirements:

 - Masters degree in Science ( mathematics  , statistics )

 - should be able mentor junior BSTs and BSAs. 

 - should have minimum 5-6 years Biostat experience , prefer sr. level experience